Enforcement Report - Week of September 19, 2012
-
| Product Type | Product Description | Code Info | Classification | Reason for Recall | Recalling Firm |
|---|---|---|---|---|---|
| Biologics | ORTHO-ProVue (TM) A modular, microprocessor-controled instrument. | MTS213784 | Class II | ORTHO ProVue, with a software glitch or defect that could lead to erroneuous results, was distributed. | Micro Typing Systems Inc. |
| Devices | CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO 3 V1.05 System is also intended to support EP procedures, maintaining CARTO· XP System capabilities, in the presence of a high metallic environment and provide a data communication channel to the Stereotaxis Niobe Catheter Guidance System as well as in a regular EP lab. The CARTO 3 V1.05 System includes the CartoMerge capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real time catheter navigation, the Fast Anatomical Mapping (FAM) functionality, enabling creation of cardiac maps using'catheters with magnetic proximal and distal location sensors and the CartoSound image integration functionality, that enables integration of intracardiac echo (ICE) visualization to provide 3D combined maps. In addition to the use of specialized navigation catheters, the system is also intended for use with non-navigational electrophysiology catheters. | FG-5400-00 | Class II | The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and other electrophysiology (EP) equipment, including the CARTO 3 Electropysiology Mapping System. | Biosense Webster, Inc. |
| Biologics | Life Technologies": BRAND NAME: ABC SSP UniTray® Kit, A Locus SSP UniTray® Kit, ABDR SSP UniTray® Kit, ABDRDQ SSP UniTray® Kit, AllSet+" Gold SSP HLA-A Locus Low Res Kit, AllSet+" Gold SSP HLA-ABC Low Res Kit, AllSet+" Gold SSP HLA-ABDR Low Res Kit, AllSet+" Gold SSP HLA-ABDRDQ Low Res Kit Invitrogen" , 9099 North Deerbrook Trail, Brown Deer, Wisconsin 53223 USA. | AllSetGoldSSPHLA-ALowResKit 54310D 021709367 021791391 021858141 021916872 021944913 0211076053; AllSetGoldSSPHLA ABCLowResKit 54340D 037736548 037791458 037841437 037887231 037912911 037981112 0371011633 0371099919; AllSetGoldSSPHLA ABDRLowResKit 54350D 035735485 035757726 035791451 035832512 035866507 035911311 035951701 0351008471 0351073440 0351103719; AllSetGoldSSPHLA ABDRDQLowResKit 54360D 027736541 027778991 028835924 028861758 028911312 028984379 0281073439 0281103699; ABCSSPUniTrayKit 7800010 037712454 037757729 037796665 037851612 037902242 037920508 037979628 0371092252; ABCSSPUniTrayKitwithTaqPolymerase 7800110 037712454752859 037712454758394 037712454760790 037712454764016 037712454766991 037712454770869 037712454771629 037712454772789 037712454774287 037712454778484 037712454778956 037712454781733 037712454788029 037712454789359 037712454790178 037757729798591 037757729797983 037757729801400 037757729804912 037757729808045 037757729812168 037757729814418 037757729815958 037757729819705 037757729821059 037757729825396 037757729827308 037757729828024 037757729830803 037796665832713 037796665834166 037796665838009 037796665838890 037796665844722 037796665847106; ABCSSPUniTrayKitwithTaqPolymerase 7800110 037796665849099 037796665850875 037796665851181 037796665852860 037796665851949 037796665857262 037796665858683 037796665865627 037796665866156 037796665869762 037796665871196 037796665874253 037796665874943 037851612880429 037851612881201 037851612883129 037851612890428 037851612895476 037851612899445 037851612900035 037851612904079 037851612904692 037851612905849 037851612907021 037851612907856 037851612910035 037851612910577 037851612914817 037851612917475 037851612919222 037851612924833 037902242932770 037902242933984 037902242935517 037902242938190 037902242940463 037902242942846 037902242943935 037902242946600 037902242977061 037920508978727 037920508985066 037920508988899; ABCSSPUniTrayKitwithTaqPolymerase 7800110 037920508991179 037920508998068 0379205081007233 0379205081008777 0379205081009666 0379205081012119 0379205081016105 0379205081017791 0379205081022104 0379205081021177 0379205081022614 0379205081025411 0379205081028018 0379205081028598 0379205081030883 0379796281034872 0379796281039558 0379796281041841 0379796281043290 0379796281044774 0379796281047614 0379796281048266 0379796281070125 0379796281073455 0379796281077182 0379796281083262 0379796281084640 0379796281092860 0379796281093721 0379796281097467 0379796281098059 0379796281099188 0379796281101573 0379796281104591 03710922521111533 03710922521113863 03710922521114554 03710922521116675 03710922521123330 03710922521124844; ABDRSSPUniTrayKit 7810010 035709363 035757737 035841438; ABDRSSPUniTrayKit 7810010 035912902 035999103 0351091909; ABDRSSPUniTrayKitwithTaqPolymerase 7810110 035709363752340 035709363757045 035709363764325 035709363770868 035709363771628 035709363784352 035709363792242 035709363794386 035757737795098 035757737801401 035757737812169 035757737820236 035757737833338 035757737835069 035757737838145 035757737851950 035757737864234 035841438883648 035841438897030 035841438900036 035841438924835 035912902946416 0359129021025412 0359991031079276 0359991031096908; ABDRDQSSPUniTrayKit 7850010 027711596 027749793 027785475 028848815 028912903 0281017323; ABDRDQSSPUniTrayKitwithTaqPolymerase7850110 027711596757044 027711596758147 027711596764014 027711596764678 027749793799826 027749793826676 027785475834613; ABDRDQSSPUniTrayKitwithTaqPolymerase7850110 027785475866155 027785475869047 028848815905848 028848815912398 028848815942043 028848815947403 028848815978967 028848815979292 028848815984697 0289129031022118 0289129031036927 02810173231045578 02810173231076646 02810173231090097; ALocusSSPUniTrayKit7860010 021751563 021825655 021912905 021999106; ALocusSSPUniTrayKitwithTaqPolymerase7860110 021751563824723 021825655924846 021825655926945 021825655928179 021825655932194 021825655935516 021912905948130 021912905951091 0219991061082229 ALocusSSPUniTrayKit7860010021751563 2010-032011-10 0218256552010-082012-04 0219129052011-032012-11 0219991062011-082013-03 ALocusSSPUniTrayKitwithTaq Polymerase 78601100217515638247232010-072011-10 0218256559248462011-022012-04 0218256559269452011-022012-04 0218256559281792011-022012-04 0218256559321942011-032012-04 0218256559355162011-032012-04 0219129059481302011-042012-11 0219129059510912011-042012-11 02199910610822292011-102013-03 | Class II | HLA typing assay, associated with false negative results, were distributed. | Life Technologies, Inc. |
| Biologics | Plasma Frozen within 24 hours (FP24) | W010711011931; W010711011963; W010711011962; W010711011951; W010711011946; W010711011939; W010711011922; W010711011929; W010711011947; W010711011957; W010711011957; W010711011943; | Class III | Blood products, labeled with an incorrect expiration date, were distributed. | D. D. Eisenhower Army Med. Ctr. - Blood Bank |
| Devices | SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin. | PN 8000809705; Serial numbers 248-1298 | Class II | The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. In some instances when the door cord is installed with little or no slack outside the upper decor piece, the cord has been known to fail causing a short in the wiring at the pivot point in the cord. | JK Products & Services, Inc |
| Veterinary | CalDensity Black Label, CalDensity White Label with HA, packaged in white plastic 5, 15, 25, 40, 60 lb pails with plastic liner and white plastic lid. | 042009, 051009, 061209, 071509, 091009, 011510, 030310, 031610, 052610, 092410, 120110, 011211, 020111, 030911, 050111, 071111 & 090111. | Class II | During an FDA inspection it was found that the CalDensity Black label and CalDensity White Label with HA product containers did not include the precautionary statement DO NOT FEED TO CATTLE OR OTHER RUMINANTS | Process Managers LLC |
| Biologics | Red Blood Cells (Apheresis) Leukocytes Reduced | W0415120158940 | Class III | Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. | Blood Systems, Inc. dba United Blood Services |
| Biologics | Red Blood Cells | W038111183305 | Class II | Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. | Florida's Blood Centers, Inc. |
| Biologics | Source Plasma | 2160062845; 2160063872; 2160065445; 2160068908; 2160071590 | Class III | Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160069348 | Class III | Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160078505; 2160079641 | Class III | Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160063807 | Class III | Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160077885; 2160078198 | Class III | Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160077908 | Class III | Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160070522; 2160080254 | Class III | Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed | Plasmacare Inc |
| Biologics | Source Plasma | 2160062561; 2160067517 | Class III | Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160079251 | Class III | Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160077780 | Class III | Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160078077 | Class III | Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160067549; 2160074048 | Class III | Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160065452 | Class III | Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. | Plasmacare Inc |
| Devices | REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. | Catalog Number 101-05-20; Serial Numbers: 2179820 and 2216759. | Class II | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition. | Exactech, Inc. |
| Devices | REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. | Catalog Number: 101-05-30. Serial Numbers:2218601 and 2218603. | Class II | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition. | Exactech, Inc. |
| Devices | REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. | Catalog Number: 101-05-40. Serial Numbers:2193123 and 2193124. | Class II | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition. | Exactech, Inc. |
| Devices | REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. | Catalog Number: 101-45-20. Serial Numbers:2138948 and 2138950. | Class II | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition. | Exactech, Inc. |
| Devices | REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. | Catalog Number: 101-45-30. Serial Numbers:2139027 and 2139028. | Class II | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition. | Exactech, Inc. |
| Devices | REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. | Catalog Number: 101-45-20. Serial Numbers:2139099 and 2139100. | Class II | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition. | Exactech, Inc. |
| Biologics | Source Plasma | 2160075750; 2160076155; 2160058983; 2160063549; 2160065677; 2160067374; 2160068963; 2160080530 | Class III | Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160058856; 2160059304; 2160062919 | Class III | Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160082868; 2160083407; 2160084296 | Class III | Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160066915; 2160067545; 2160076395 | Class III | Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160066934; 2160068103; 2160069088; 2160071419; 2160072603; | Class III | Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | Plasmacare Inc |
| Biologics | Source Plasma | 2160065002; 2160071557; 2160072847; 2160084133 | Class III | Blood Products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | Plasmacare Inc |
| Biologics | Blood and Blood Products for Reprocessing | 041LS92218 | Class III | Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. | American Red Cross Blood Services |
| Biologics | Blood and Blood Products for Reprocessing | 2721483 | Class III | Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed. | Community Blood Centers of Florida, Inc. |
| Biologics | Red Blood Cells | 2721483 | Class II | Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed. | Community Blood Centers of Florida, Inc. |
| Biologics | Blood and Blood Products for Reprocessing | 2564980 | Class III | Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. | Community Blood Centers of Florida, Inc. |
| Biologics | Fresh Frozen Plasma | 2625072 | Class II | Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. | Community Blood Centers of Florida, Inc. |
| Biologics | Red Blood Cells | 2564980; 2625072 | Class II | Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed | Community Blood Centers of Florida, Inc. |
| Biologics | South Dakota Lions Eye Bank, Cornea, SD11-079, For single use only, Not considered sterile, Culturing Recommended. | SD11079OD; SD11079OS | Class II | Human Corneas, recovered from a donor who had not been properly evaluated, were distributed. | South Dakota Lions Eye and Tissue Bank, Inc. |
| Devices | Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps. | catalog number 16404 and serial numbers: 4357, 4381, 4386, 4387, 4389, 4391, and 4392. | Class II | Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations have been adjusted to avoid mix-ups of different current rated circuit breaker. Terumo CVS implemented a requirement to ensure that assembly associates verify the values of electrical components in process to avoid such mix ups. At the time the problem was discovered, an NCR was opened to document that all remaining inventory at Terumo CVS had the correct circuit breaker installed. All Safety Monitors at Terumo CVS were verified to have the correct circuit breaker. Terumo CVS received complaints in 2009, at which time corrective action was completed for devices in the field. These corrections were not reported to the agency at that time. | Terumo Cardiovascular Systems Corporation |
| Devices | Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician | Philips HeartStart MRx monitor/defibrillators manufactured prior to June 2012 and used in external transport and Emergency Medical Service (EMS) environments, distributed worldwide | Class II | Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables | Philips Healthcare Inc. |
| Biologics | Platelets Pheresis Leukocytes Reduced Irradiated | W040712445641; | Class II | Blood product, which did not meet acceptable product specifications, was distributed. | Indiana Blood Center |
| Biologics | Red Blood Cells | W045611821798; | Class II | Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. | Community Blood Bank of Erie County |
| Biologics | Platelets Pheresis Leukocytes Reduced | W1151121920149; | Class II | Blood product, which did not meet acceptable product specifications, was distributed. | LifeSouth Community Blood Centers Inc - Birmingham Region |
| Biologics | Fresh Frozen Plasma | W041111083987D; | Class II | Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. | Blood Systems, Inc. dba United Blood Services |
| Food/Cosmetics | AquaRoyale Oyster IQF Packed By Dai One Food.Co., LTD. Packed For: Sunny Seafoods, Inc. 11 Sunflower Avenue, Paramus, NJ 07652. USA NET WT.: 20 LBS (40/8oz) ICSSL No. KR-8-SP | All Lots between 1/01/2010 and 3/01/2012. | Class II | This recall was mandatory by the States. Frozen Oysters from Korea is considered adulterated. First found out by one of our customer in NY called Sunny Seafoods on 5/07/12 asking about the recall. Inspector from NY Dept. of Health notified our customer. Oyster farming area in Korea found to be adulterated. | Sunny Seafoods Inc |
| Food/Cosmetics | Frozen Cooked Oyster: 1) Cooked Oyster 40-90 CT/LB IQF Packed By: Dai One Food.Co., LTD. Country of Origin: Republic of Korea. NET WT.: 40 LBS with 8 LBS Glaze; ICSSL No. KR-8-SP 2) AquaRoyale FROZEN COOKED OYSTER IQF PACKED FOR: SUNNY SEAFOODS INC. 11 SUNFLOWER AVENUE, PARAMUS, NJ 07652 U.S.A. NET WT.: 4 LBS (1/40 LBS) PACKED BY DAI ONE FOOD CO., LTD. ICSSL NO. KR-8-SP. | 1 & 2: All Lots between 1/01/2010 and 3/01/2012 | Class II | This recall was mandatory by the States. Frozen Oysters from Korea is considered adulterated. First found out by one of our customer in NY called Sunny Seafoods on 5/07/12 asking about the recall. Inspector from NY Dept. of Health notified our customer. Oyster farming area in Korea found to be adulterated. | Sunny Seafoods Inc |
| Food/Cosmetics | Half Shell Oyster Imported By: KORYEO INT'L CORP 200 STEWART AVENUE, BROOKLYN, NY 11237; SPEC 72PCS; COUNTRY OF ORIGIN: REPUBLIC OF KOREA; METHOD OF PRODUCTION: FARM RAISED; ICSSL No. KR-8-SP | All Lots between 1/01/2010 and 3/01/2012. | Class II | This recall was mandatory by the States. Frozen Oysters from Korea is considered adulterated. First found out by one of our customer in NY called Sunny Seafoods on 5/07/12 asking about the recall. Inspector from NY Dept. of Health notified our customer. Oyster farming area in Korea found to be adulterated. | Sunny Seafoods Inc |
| Biologics | Red Blood Cells (Apheresis) Leukocytes Reduced | W041112035793X; | Class II | Blood products, which did not meet the acceptable product specifications, were distributed. | Blood Systems, Inc. dba United Blood Services |
| Biologics | Red Blood Cells (Apheresis) Leukocytes Reduced | W041112032780H; | Class II | Blood products, which did not meet the acceptable product specifications, were distributed. | Blood Systems, Inc. dba United Blood Services |
| Biologics | Blood and Blood Products for Reprocessing | W038111208369; W038110158215; | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. | Florida's Blood Centers, Inc. |
| Biologics | Source Plasma | SA0006509; SA0007428; SA0008238; SA0009496; SA0009707; | Class II | Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. | Dci Biologicals Llc |
| Biologics | Red Blood Cells Leukocytes Reduced | W141412016763; | Class II | Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. | Meek Blood Center |
| Biologics | Red Blood Cells | W038111183306; | Class II | Blood product, which was collected from a donor who lived in a malarial endemic area, was distributed. | Florida's Blood Centers, Inc. |
| Biologics | Platelets Pheresis Leukocytes Reduced | W1151121360646; | Class II | Blood product, which did not meet acceptable product specifications, was distributed. | LifeSouth Community Blood Centers Inc - Birmingham Region |
| Biologics | Red Blood Cells Leukocytes Reduced | W036312000290; | Class II | Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. | BloodCenter of Wisconsin, Inc |
| Biologics | Red Blood Cells Leukocytes Reduced | W158011201964; | Class II | Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed | Arup Laboratories, Inc. |
| Biologics | Red Blood Cells Leukocytes Reduced | W045010076930; W045010092946; W045010092946; W045011029587; W045011012156; W045011012156; W045012002820; W045012002820; | Class II | Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. | Community Blood Center Of Gtr KC |
| Veterinary | BLN Fescue Forage Blend CTC NB-0451, Type B Medicated Feed For Beef Cattle, containing 1.4 g/lb. chlortetracycline, packaged in 50-lb. bags. The tag is labeled Manufactured by: Nutra Blend, LLC, Neosho, MO. The bag lists the firm name as Bass Livestock Nutrition, LLC, Rogersville, MO. | Lot 0525264 | Class II | The feed contains excessive levels of selenium | Nutra Blend LLC |
| Food/Cosmetics | Finest Traditions Smokey Baked Beans, 8 lbs.,10 733147 10456 6, 16 oz., 7 33147 00161 5, 8 lbs., 10 733147 10231 9; | Finest Tradiitons Smokey Baked Beans, 38698, 8/15/12-8/20/12, 38854, 08/15/12-08/22/12 & 38700, 8/15/12-8/20/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Anti Pasto Salad Base, Net Wt. 4 lbs., UPC 0 11596 65634 2 | Product Code 5634B with Date codes 8/17/2012-8/20/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Pickled Beet And Onion Salad, Net Wt. 5 lbs., UPC 0 11596 52051 3 | Product Code 2051 with Date codes 08/14/12-08/17/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Acme Creamed Cabbage, Net Wt. 16 oz., UPC 0 11596 14025 1 | Product Code 4025 with Date codes 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Creamy Cole Slaw packaged under the following brand, salad name, container size, and UPC number: 1) Garden-Fresh Creamy Cole Slaw Kit , 6 lbs., 0 11596 63039 7; 2) Spartan Creamy Shredded Cole Slaw, 16 oz., 0 11213 90322 4, & 3 lbs., 0 11213 90327 9; 3) Garden-Fresh Creamy Shredded Cole Slaw, 16 oz., 0 11596 1402 3, 2 lb., 011596 24203 3, 5 lb., 0 11596 93014 5, 8 lb., 0 11596 53005 5; 4) Weis Creamy Cole Slaw, 16 oz., 0 41497 05837 2 , 3 lb., 0 41497 059906 5, 5 lb., 0 1596 53101 4 | 1) Garden-Fresh Creamy Cole Slaw Kit , 3039, 07/27/12-07/31/12; 2) Spartan Creamy Shredded Cole Slaw, 4072, 8/16/2012 & 4372, 8/16/2012; 3) 4022, 08/14/12-08/20/12, 4203, 8/15/2012, 3014, 8/15/2012-8/17/2012, 3005, 8/72012; 4) 05837, 8/14/12-8/16/12, 05906, 8/13/12-8/14/12, 3101, 8/16/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Rogges Sour Cream Cuke Salad, 5 lbs., UPC 0 11596 52057 5 | Rogges Sour Cream Cuke Salad, 2057, 8/7/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Archer Farms Layered Taco Dip Kits - Taco Dip, kit, 0 11 11596 36300 4 | Archer Farms Layered Taco Dip Kits - Taco Dip, Kits, 8/24/2012. | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Chef's Kitchen Deluxe Egg Salad, 5 lbs., 0 11596 52044 5 | Chef's Kitchen Deluxe Egg Salad, 2044, 8/8/2012-8/15/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | German Potato Salads packaged under the following brand, dip name, container size, and UPC number: 1. Copperwood Kitchens German Potato Salad, 5 lbs., 8 11839 01033 3; 2. Garden-Fresh German Potato Salad, 16 oz., 0 11596 14017 9 ,3 lbs., 0 11596 34319 8 , 5 lbs., 0 11596 91020 8 3. Grandpa's German Potato Salad, 5 lbs., 0 11596 91023 9 | 1. Copperwood Kitchens German Potato Salad, 810333, 8/16/2012 2. Garden-Fresh German Potato Salad, 4017, 8/13/2012-8/15/2012, 4319, 8/13/2012 & 1020, 8/13/2012-8/20/2012 3. 1023, 08/13/12-08/16/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | DF Homemade macaroni Salad, 5 lbs., 0 70163 89080 0 ; | DF Homemade macaroni Salad, 401140, 8/22/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Potato Pancakes 4 lbs. 0 11596 40425 5 | Garden-Fresh Potato Pancakes 0425 08/10/12-08/15/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Weis Spiral Pasta Salad, 5 lbs, 0 11596 52107 7 | Weis Spiral Pasta Salad, 2107, 8/15/2012 - 8/16/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Bacon Mac & Cheddar Salad Kit 5.75 lbs. 0 11596 62209 5 | Garden-Fresh Bacon Mac & Cheddar Salad base 2209B 08/14/12-08/16/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Tomato Mozzarella Salad Kit 4 lbs. 0 11596 55163 0 | Brand, Product name, Product Code and Date Code: Garden-Fresh Tomato Mozzarella Salad Kit 5163 08/04/12-08/10/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Smoked Imitation Salmon, 12 oz., 7 33147 00127 1; 8 lbs., 10 733147 10120 6 | 38954, 08/15/12-08/22/12; 38736, 08/15/12-08/22/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Fresh Salsa, 15 oz., 0 11596 06137 5; 5 lbs.,0 11596 59010 3; 5 lbs., Roundys Fresh Salsa, 0 11596 59011 0; 15 oz., 0 11596 06117 7 | 6137, 8/20/2012; 9010, 8/24/2012-8/27/2012; 9011, 8/25/2012-8/26/2012; Roundys Fresh Salsa, 6117, 8/25/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Spinach Dip, 8 oz., 7 33147 10538 2 | 38992, 08/15/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Tuna Salad packaged under the following brand name, container size, UPC code: Finest Traditions Tuna Salad Spread 12 oz. 7 33147 10487 3 Finest Traditions Tuna Salad Spread 4 lbs. 10 733147 10186 2 Garden-Fresh Premium Tuna Salad 5 lbs. 0 11596 55101 2 Market Pantry Tuna Salad 12 oz. 0 85239 24108 0 Weis Tuna Salad 8 oz. 0 41497 05345 2 | Brand, Product name, Product Code and Date Code: Finest Traditions Tuna Salad Spread 38622 08/20/12-08/25/12 Finest Traditions Tuna Salad Spread 38620 08/25/12 Garden-Fresh Premium Tuna Salad 5101 08/18/12-08/25/12 Market Pantry Tuna Salad 24108 8/18/2012-8/25/2012 Weis Tuna Salad 5345 8/18/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Garden Vegetable Spaghetti 8 lbs., 10 733147 10196 1 | 38612, 08/15/12-08/20/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Wild Rice Salad Base, 8 lbs., 10 733147 10183 7 | 38668, 08/15/12-08/22/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Family Style Creamy Tuna Salad 5 lbs. 0 11596 55108 1 | Brand, Product name, Product Code and Date Code: Garden-Fresh Family Style Creamy Tuna Salad 5108 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Fresh Mango Salsa 5 lbs. 0 11596 59025 3 | Garden-Fresh Fresh Mango Salsa 9025 8/26/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Black Bean Salsa, 15 oz., 0 11596 06118 4 Garden-Fresh Black Bean Salsa, 5 lbs., 0 11596 52587 7 | Garden-Fresh Black Bean Salsa, 6118, 08/25/12; Garden-Fresh Black Bean Salsa, 52587, 8/24/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Fat Free Black Bean Salsa, 8 lb., 10 733147 10181 7 | Finest Traditions Fat Free Black Bean Salsa, 38694, 08/15/12-08/22/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Baked Potato Salad Kit, 5 lb., 0 11596 61071 9 | Garden-Fresh Baked Potato Salad Kit, 1071B, 08/13/12-08/20/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Knowlan's Club Salad Base, 8 lb.,10 733147 10201 5 | Knowlan's Club Salad Base, 39076, 08/15/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Copperwood Kitchens Greek Style Pasta Salad 5 lbs. 8 11839 01032 6 Garden-Fresh Greek Style Pasta Salad 5 lbs. 0 11596 52035 3 | Copperwood Kitchens Greek Style Pasta Salad, 8103, 8/16/2012 Garden-Fresh Greek Style Pasta Salad 2035 8/13/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Bow Tie Pastas: 1) Copperwood Kitchens Venetian Bow Tie Pasta, 5 lbs., 8 11839 01031 9; 2) Garden-Fresh Venetian Bowtie Pasta, 5 lbs., 0 11596 520278 | 1) 81031908/14/12-08/20/12; 2) 2027, 08/16/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Pea & Cheese Pasta Salad, 8 lb., 10 733147 10146 6 | Finest Traditions Pea & Cheese Pasta Salad, 38688, 08/15/12-08/22/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Rigatoni Pasta Salad, 8 lb., 10 733147 10148 0 | Finest Traditions Rigatoni Pasta Salad, 38666, 08/15/12-08/22/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh California Pasta Salad, 5 lbs, 0 11596 82068 2 Garden-Fresh California Pasta Salad, 5 lbs., 0 11596 52115 2 | 2068, 8/11/2012-8/15/2012; 2115, 08/10/12-08/11/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Italian Pasta Salad: 1) Garden-Fresh Italian Pasta Salad, 8 lbs., 0 11596 92012 4; 2) Market Pantry Italian Pasta Salad 14 oz., 0 85239 20119 0 | 1) 2012, 8/17/12 - 8/20/12; 8/14/12-8/21/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Ranch Pasta Salad, 5 lb., 0 11596 52202 9 | Garden-Fresh Ranch Pasta Salad, 2202, 8/13/2012-8/15/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Seafood Pasta Salad, 5 lb., 0 11596 55007 7 | Garden-Fresh Seafood Pasta Salad, 5007, 08/14/12-08/20/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Southwestern Pasta Salad, 5 lb., 0 11596 52046 9 | Garden-Fresh Southwestern Pasta Salad, 2046, 08/13/12-08/16/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Taco Pasta Salad: 1) Garden-Fresh Taco Pasta Salad, 5 lbs., 0 11596 52076 6; 2) Garden-Fresh Taco Pasta Salad, 5 lbs., 0 11596 52065 0 | 1) 2076, 08/14/12-08/20/12; 2) 2065, 08/13/12-08/15/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Our Own Fettuccine Pasta Salad, lb., 0 11596 52150 | Our Own Fettuccine Pasta Salad, 2150, 8/15/2012- 8/20/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | DF Special Recipe Macaroni Salad, 16 oz., 0 70163 98110 2 | DF Special Recipe Macaroni Salad, 98110, 8/25/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Creamy Cheddar Macaroni , 8 lbs., 10 733147 10156 5 | Finest Traditions Creamy Cheddar Macaroni , 38888, 08/13/12-08/22/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Macaroni Salad, 16 oz., 7 33147 00018 2, 3 lbs., 7 33147 00032 8 & 8 lbs., 10 733147 10140 4; | Finest Traditions Macaroni Salad, 38856, 08/08/12-08/15/12, 38982, 08/13/12 & 38552, 08/08/12-08/13/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Amish Country macaroni Salad, 2010, 5 lbs, 011596520100 Weis Amish Macaroni Salad: 05844, 16 oz, 41497058440. 2105, 5 lbs, 11596521053 05905, 3 lbs, 41497059058 | Garden-Fresh Amish Country Macaroni Salad: 2010 08/15/12 Weis Amish Macaroni Salad : 05844 8/16/2012 2105 8/14/2012 - 8/16/2012 05905 8/14/2012 - 8/16/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Family Style Macaroni Salad 2060 5 lbs 0 11596 52060 5 | Garden-Fresh Family Style Macaroni Salad 2060 8/15/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Macaroni Salads: 1) Garden-Fresh Macaroni Salad, 0 11596 14018 6, 16 oz., 4018, 0 11596 52005 6, 5 lbs., 20050 11596 34305 1, 3 lbs., 4305, 0 11596 24210 1, 2 lbs., 4210 2) Spartan Macaroni Salad 11213903262 3 lbs 4373 11213903217 16 oz 4073 3) Finest Traditions Macaroni Salad, 16 oz., 7 33147 00018 2, 3 lb., 7 33147 00032 8 , 8 lb., 10 733147 10140 4 4) Market Pantry Macaroni Salad, 216240101, 3 lb., 4101 216240105, 16 oz., 24105 | 1) Garden-Fresh Macaroni Salad 4018 8/14/2012 - 8/20/2012 Garden-Fresh Macaroni Salad 2005 8/15/2012 - 8/16/2012 Garden-Fresh Macaroni Salad 4305 8/20/2012 Garden-Fresh Macaroni Salad 4210 8/15/2012 2) Spartan Macaroni Salad 4373 8/16/2012 - 8/20/2012 Spartan Macaroni Salad 4073 8/14/2012 3) 38856, 08/0812-08/15/12, 38982, 08/13/12, 38552, 08/08/12-08/13/12 4) 24101, 8/22/2012; 24105, 8/20/2012-8/26/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Copperwood Kitchens Deviled Egg Potato Salad, 00295, 8/15/2012-8/20/2012 | Copperwood Kitchens Deviled Egg Potato Salad, 00295, 8/15/2012-8/20/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Deluxe Egg Salad, 5 lbs., 0 11596 52043 8 & 5 lbs., 0 11596 52122 0; | Garden-Fresh Deluxe Egg Salad, 2043, 8/8/2012-8/15/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Deviled Egg Salad, 5 lbs, 0 11596 521220 | Garden-Fresh Deviled Egg Salad , 2122, 8/12/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Egg Salads: Garden-Fresh Egg Salad, 5 lbs., 0 11596 52022 3 & 5 lbs., 0 11596 52053 Weis Egg Salad, 8 oz., 0 41497 05365 0 & 5 lbs., 0 11596 55221 7 | Garden-Fresh Egg Salad, 2022, 8/2/2012-8/4/2012 & 2053, 8/11/2012 Weis Egg Salad, 05365, 8/9/2012-8/16/2012 & 5221, 8/11/2012-8/15/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Egg Salad Spreads: 1) Garden-Fresh Egg Salad Spread, 5 lbs., 0 11596 52053 7; 2) Finest Traditions Egg Salad Spread, 12 oz., 7 33147 10491 0 & 4 lbs., 10 733147 10189 | 1) Garden-Fresh Egg Salad Spread, 5168, 8/10/2012-8/17/2012 2) 5168, 8/10/12-8/17/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Roundy's Old Fashioned Cream Dill Dip, 12 oz., 0 11150 52603 6 | Brand, Product name, Product Code and Date Code: Roundy's Old Fashioned Cream Dill Dip, 52603, 09/09/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Sweet and Sour cucumber, 5 lbs., UPC 0 11596 52014 8; | Brand, Product name, Product Code and Date Code: Garden-Fresh Sweet and Sour cucumber, 2014, 08/06/12-08/10/12, | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Grandpas Sour Cream Cucumbers Salad, 5 lbs., UPC 0 11596 52080 3; | Grandpas Sour Cream Cucumbers Salad, 2080, 8/5/2012-8/10/2012 & | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Cranberry Walnut Red Cabbage Slaw Base, 8 lbs., 0 11596 83028 5; | Garden-Fresh Cranberry Walnut Red Cabbage Slaw Base, 3028B, 08/16/12-08/20/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Creamy Cole Slaw Dressing , 2 lbs., 0 11596 43200 7 | Garden-Fresh Creamy Cole Slaw Dressing , 3200, 09/09/12-09/15/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Cole Slaws: 1) Spartan Cole Slaw, 1 lb., 0 11213 90322 4, & 3 lbs., 0 11213 90327 9; 2) Market Pantry Cole Slaw, 15 oz., 0 85329 24106 6, & 44 oz., 0 85239 24114; 3) Spoon River Cole Slaw, 3 lb., 0 11596 34238 2 | 1) Spartan Cole Slaw, 4072, 08/14/12-08/20/12 & 4372, 08/16/12-08/20/12; 2) Market Pantry Cole Slaw, 24106, 8/19/2012 & 24106, 8/20/2012-8/25/2012; 3) 44238, 8/15/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Dixie Cole Slaws:1) Garden-Fresh Dixie Cole Slaw, 5 lbs., 0 11596 93007 7 ; 2) DF Special Recipe Dixie Cole Slaw, 16 oz. 0 70163 98115 7 | 1) Garden-Fresh Dixie Cole Slaw, 3007, 8/16/2012-8/17/2012 ; 2) DF Special Recipe Dixie Cole Slaw, 98115, 8/25/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Amish Country Cole Slaw, 5 lbs., 0 11596 53010 9; | Garden-Fresh Amish Country Cole Slaw, 3010, 08/15/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Homemade-Style Cole Slaw, 8 lbs., 10 733147 10170 1; Finest Traditions Homemade Style Cole Slaw, 16 oz., 7 33147 00025 0; | Finest Traditions Homemade-Style Cole Slaw, 38562, 08/13/12-08/20/12 Finest Traditions Homemade Style Cole Slaw, 38858, 08/13/12-08/20/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions XTRA Creamy Cole Slaw, 8 lbs., 10 733147 10017 9; | Finest Traditions XTRA Creamy Cole Slaw, 39000, 8/20/2012-8/22/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Creamy Country Cole Slaw, 8 lbs., 10 733147 10172 5; | Finest Traditions Creamy Country Cole Slaw, 38554, 08/13/12-08/22/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Black Bean Couscous, 5 lbs., 0 11596 55620 8 | Garden-Fresh Black Bean Couscous, 5620, 08/06/12-08/13/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Kidney Bean Salad , 5 lbs., 0 11596 52016 | Garden-Fresh Kidney Bean Salad , 2016, 8/14/2012 - 8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Archer Farms Four Bean Salad, 14 oz., 0 85239 24207 0 | Archer Farms Four Bean Salad, 242070, 8/23/2012-8/30/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Fat Free Bean Salad, 8 lbs., 10 733147 10180 0 | Finest Traditions Fat Free Bean Salad, 38644, 08/15/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Acme Classic Potato Salad 16 oz. 0 11596 14030 5 | Acme Classic Potato Salad, 4030, 8/14/2012 - 8/20/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Potato Salad with Egg: 1) Acme Homestyle Egg Potato Salad, 16 oz. 0 11596 14005 3; 2) Weis Potato w/ Egg Salad, 16 oz., 0 41497 05841 9, 3 lb., 0 41497 05902 7, 5 lb., 0 11596 51101 6 | 1) Acme Homestyle Egg Potato Salad , 4005, 8/17/2012 ; 2) Weis Potato w/ Egg Salad, 05841, 8/15/2012-8/16/2012, 05902, 8/14/2012-8/16/2012 & 1101, 8/13/2012-8/16/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Homestyle Potato Salads: 1) Acme Homestyle Potato Salad, 2 lbs. 0 11596 34209 2 ; 2) Finest Traditions Homestyle Potato Salad, 16 oz., 7 33147 00019 9, 3 lb., 7 33147 00031 1 , 8 lb., 10 733147 10134 3 | 1) Acme, 4209, 8/14/2012-8/17/2012; 2) Finest Tradition, 38860, 08/15/12, 38980, 08/13/12-08/20/12, 38640, 08/15/12-08/20/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Mustard Potato Salads: 1) Copperwood Premium Mustard Potato Salad, 2 lbs., 8 11839 01001 2, 5 lbs.; 2) Dairy Fresh Mustard Potato Salad, 0 070163 89090 9, 5 lbs.; 3) Garden Fresh Mustard Potato Salad, l lb., 0 11596 14010 0, 2 lb. 0 11596 24215 6; 4) Market Pantry Mustard Potato Salad, 16 oz., 0 85239 24104 2, 3 lb., 0 85239 24100 4; 5) Spartan Mustard Potato Salad, 1 lb., 0 11213 90319 4, 3 lb., 0 11213 90324; 6) Spoon River Mustard Potato Salad, 3 lb., 0 11596 24207 8; 7) Rogges Mustard American Potato Salad, 5 lb., 0 11596 51053 3 | 1) Copperwood, 01001, 8/15/2012, 01029, 8/15/2012-08/17/12; 2) Dairy Fresh, 401536, 8/20/2012; 3) Garden Fresh, 4010, 8/14/2012, 4215, 8/15/2012; 4) Market Pantry, 24104, 8/19/20128/25/2012, 24100, 8/21/2012; 5) Spartan, 4071, 8/7/20128/14/2012, 4371, 8/13/2012-8/20/2012 ;6) Spoon River, 4207, 8/14/2012; 7) Rogges, 1053, 8/11/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Steakhouse Potato Salads: 1) Copperwood Steakhouse Potato Salad, 5 lbs., 8 11839 01001 7, 5 lb.; 2) Grandpas Steakhouse Potato Salad, 5 lb., 0 11596 55604 8; 3) Finest Traditions Steak House Potato Salad, 8 lb., 10 733147 10773 4 | 1) Copperwood, 01014, 8/15/2012; 2) 5604, 08/13/12-08/20/12; 3) Finest Traditions, 38292, 08/15/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Dairy Fresh Special Recipe Potato Salad, 5 lbs., 0 70163 40659 7, 5 lbs. | 98135, 8/22/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Premium Potato Salads: 1) Copperwood Premium Potato Salad, 2 lb., 8 11839 01000 5, 5 lb., 8 11839 01016 6; 2) Our Own Premium Potato Salad, 5 lb., 0 11596 91045 1 | 1) Copperwood, 01000, 8/15/2012-08/17/12, 0106, 8/15/2012 ; 2) Our Own, 1045, 8/10/2012-8/12/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Dairy Fresh Baked Potato Salad, 5 lb., 0 70163 40659 | 406599, 8/22/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Dairy Fresh Special Recipe Mustard Potato Salad, 16 oz.., 0 70163 98105 8 | 98105, 8/22/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Dairy Fresh Special Recipe Potato Salad, 16 oz.., 0 70163 98135 5 | 98135, 8/22/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Blue Cheese Potato Salad, 8 lb., 10 733147 10137 4 | 38760, 08/01/12-08/08/12 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Deluxe Potato Salad, 16 oz., 7 33147 00007 6, 3 lb., 7 33147 00030 4, 8 lb., 10 733147 10130 5, 8 lb., 10 733147 10450 4 | 38768, 08/15/12-08/20/12, 38568, 08/20/12, 38978, 08/15/12-08/20/12, 38536, 08/15/12-08/20/12 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Finest Traditions Roasted Garlic Potato Salad, 8 lb., 10 7 33147 10159 6 | 38580, 08/15/12-08/22/12 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | American Potato Salads: 1) Garden-Fresh American Potato Salad, 1 lb., 0 11596 14015 5, 2 lb., 0 11596 24200 2; 2) Market Pantry American Potato Salad, l lb., 0 85293 24107 3, 3 lb., 0 85239 24102 8; 3) Spartan American Potato Salad, 3 lb., 0 11213 90325 5 | 1) Garden-Fresh, 4015, 08/17/12, 4200, 08/15/12; 2) Market Pantry, 24107, 9/19/2012-8/25/2012; 3) Spartan, 4370, 8/16/2012-8/20/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Amish Potato Salads: 1) Garden-Fresh Amish Country Potato Salad, 5 lb., 0 11596 51005 7; 2) Weis Amish Potato Salad, 16 oz., 0 41497 05845 7, 3 lb., 0 41497 05901 0, 5 lb., 0 11596 51103 0 | 1) Garden-Fresh, 1005, 8/17/12; 2) Weis, 1103, 8/14/2012-8/16/2012, 05845, 8/14/2012-8/16/2012, 05901, 8/14/2012-8/16/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Country Style Potato Salad, 5 lb., 0 11596 51075 0 | 1075, 08/20/12 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Family Style Potato Salad, 5 lb., 0 11596 51061 3 | 1061, 8/14/2012-8/15/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Gourmet Dill Potato Salad, 5 lb., 0 11596 55137 1 | 5137, 8/7/2012-8/9/2012, 5132, 8/15/2012-8/16/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Large Diced American Potato Salad, 5 lb., 0 11596 91018 5 | 1018, 8/16/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Red Potato Salads: 1) Garden-Fresh Red Potato Salad, 2 lb., 0 11596 24205 7; 2) Weis Red Potato Salad, 16 oz., 0 41497 05848, 5 lb., 0 11596 51105 4 | 1) Garden-Fresh, 4205, 08/16/12; 2) Weis, 05848, 8/14/2012-8/16/2012, 1105, 8/14/2012-8/16/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Reduced Fat American Potato Salad, 5 lb., 0 11596 51201 2 | 1201, 08/20/12 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Reduced Fat Mustard Potato Salads: 1) Garden Fresh Reduced Fat Mustard Potato Salad, 5 lb., 0 11596 51202 0; 2) Market Pantry Reduced Fat Mustard Potato Salad, 16 oz., 0 85239 20016 2 | 1) Garden-Fresh, , 1202, 08/14/12; 2) Market Pantry, 200162, 08/14/12 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Deviled Egg Potato Salads: ) Grandpas Deviled Egg Potato Salad, 1 lb., 0 11596 14012 4; 5 lb., 0 11596 51065 1; 3.5 oz., 0 11596 08005 5; 2) Copperwood Kitchens Deviled Egg Potato Salad, 00295 | 1) ; 2) 8/15/2012-8/20/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Grandpas Potato Salad, 16 oz., 0 11596 14027 8; 8.2 lb., 0 11596 24227 9; 3 lb., 0 11596 34326 6; 5 lb., 0 11596 91026 0 | 4027, 8/14/2012-8/17/2012, 4227, 08/17/12, 4326, 8/15/2012-8/20/2012, 8005, 08/20/12, 1026, 8/15/2012-8/20/2012 Acme Homestyle Potato Salad, 4209, 8/14/2012-8/17/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Grandpas Red Skin Potato Salad, 5 lb., 0 11596 51080 4 | 1080, 08/17/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Spoon River Potato Salad, 5 lb., 0 11596 51032 3 | 1032, 8/14/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Marsh's Signature Potato Salad, 5 lb., 0 11596 51085 9 | 1085, 8/13/2012-8/15/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Rogges White Potato Salad, 5 lb., 0 11596 51052 1 | 1052, 8/11/2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Weis Original Potato Salad, 16 oz., 0 41497 05838 9, 3 lb., 0 41497 05900 3, 5 lb., 0 11596 51102 3 | 05838, 8/14/2012-8/16/2012, 05900, 8/14/2012-8/16/2012, 1102, 8/14/2012-8/20-2012 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Acme Homestyle Cole Slaw, 16 oz., 0 11596 14304 3 | 4034, 8/5/12-8/17/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | Garden-Fresh Family Style Cole Slaw, 5 lb., 0 11596 53060 4 | 3060, 8/16/12 | Class I | Recalled salads, slaw, salsa, bean and dips contained onions that were recalled by Gills Onions due to potential Listeria monocytogenes contamination. | Garden-Fresh Foods, Inc. |
| Food/Cosmetics | The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. BABY SHRIMP SALAD | These products were sold by the pound. | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. BEET & GOAT CHEESE SALAD WITH RASPBERRY VINAIGRETTE | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Beet Dressing sold at the chef's case, self service bar, or sold packaged. Packaged product is labeled as listed below: "WHOLE FOODS MARKET***BEET DRESSING***RED BEETS, HONEY, GARLIC, ONIONS, CANOLA MAYONNAISE (CANOLA OIL, EGGS, HONEY, VINEGAR, SALT, SPICES, LEMON JUICE), APPLE CIDER VINEGAR (APPLE CIDER VINEGAR, WATER) CONTAINS: EGGS***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. CHUNKY RANCH VEGETABLE SALAD NO OIL ADDED | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Cranberry Tuna Salad Roll sold at the chef's case, self service bar, or packaged. Packaged product is labeled as listed below: "WHOLE FOODS MARKET***CRANBERRY TUNA SALAD ROLL 2 FOR 5***BREAD (UNBLEACHED UNBROMATED WHEAT OR WHOLE WHEAT FLOUR, WATER, FLORIDA CRYSTALS SUGAR, PALM OIL, EGGS, NON FAT DRY MILK, ASCORBIC ACID, SALT, YEAST, CULTURED WHEAT FLOUR, SOY LECITHIN & NATURAL ENZYMES), TUNA (TUNA, WATER, VEGETABLE BROTH (CARROTS & PEAS), SALT), ONIONS, SUN-DRIED CRANBERRIES (CRANBERRIES, EVAPORATED CANE SUGAR), CANOLA MAYONNAISE (CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE), LEMONS, TOMATO, LETTUCE CONTAINS: WHEAT, EGGS, MILK, SOY, FISH***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The Thousand Island Potato Salad is sold at the chef's case, self serve counter, or packaged.It is also sold as "Family Sized Savings Thousand Island Potato Salad". Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***THOUSAND ISLAND POTATO SALAD***POTATOES, CAGE-FREE HARD COOKED EGGS (EGGS, WATER, CITRIC ACID), THOUSAND ISLAND DRESSING....***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Miso Dressing sold at the chef's case, self service bar, or sold packaged. Packaged product is labeled as listed below: "WHOLE FOODS MARKET***MISODRESSING***WHITE MISO (WATER, RICE, WHOLE SOYBEAN, SEA SALT, KOJI STARTER), TOFU (FILTERED WATER, (NON-GMO) SOYBEANS, NATURAL COAGULANTS (CALCIUM CHLORIDE (NIGARI), CALCIUM SULFATE), EXTRA VIRGIN OLIVE OIL, WATER, APPLE CIDER VINEGAR (APPLE CIDER VINEGAR, WATER), ONIONS, TAMARI (WATER, SOYBEANS, SALT, ALCOHOL (TO PRESERVE FRESHNESS)), PARSLEY CONTAINS: SOY***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. MISO KISSED CUKES | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | New York City Corned Beef on Rye sold at the chef's case, or packaged. Packaged product is labeled as listed below: "WHOLE FOODS MARKET***FANCY REUBEN SANDWICH WITH PASTRAMI OR CORNED BEEF***PASTRAMI OR CORNED BEEF (BEEF, WATER, SEA SALT, SUGAR, BEET POWDER, GARLIC POWDER, SPICES, GARLIC, BAY LEAF, MUSTARD SEED, ALLSPICE) HONEY MUSTARD COLESLAW ( GREEN & RED CABBAGE, CARROTS), HONEY MUSTARD DRESSING ( DIJON MUSTARD (DISTILLED VINEGAR, WATER, MUSTARD SEED, SALT, WHITE WINE, CITRIC ACID, TARTARIC ACID, SPICES, TURMERIC), WHOLEGRAIN MUSTARD ( WATER, GRAIN VINEGAR, MUSTARD SEED, SALT, SPICES), LEMON JUICE, CANOLA MAYONNAISE ( CANOLA OIL, EGGS, HONEY, VINEGAR, SALT, SPICES, LEMON JUICE), HONEY), OR CLASSIC COLESLAW ( GREEN & RED CABBAGE, CARROTS, CANOLA MAYONNAISE, HORSERADISH ( HORSERADISH, WATER, VINEGAR, SALT, NATURAL FLAVORINGS), SUGAR, FENNEL, LEMON PEPPER, CELERY SEED, APPLE CIDER VINEGAR (APPLE CIDER VINEGAR, WATER), SWISS CHEESE ( PART SKIM MILK, CHEESE CULTURE, SALT, ENZYMES), BREAD CIABATTA (ENRICHED WHEAT FLOUR ( WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID), WATER, CANOLA OIL, EXTRA VIRGIN OLIVE OIL, RYE SOURDOUGH FLAVOR, SALT, YEAST). CONTAINS: MILK, EGGS, SOY, WHEAT.***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. PASTA WITH LONG BEANS & ARAME IN CREAMY BEET VINAIGRETTE | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Ranch Dressing No Oil Added sold at the chef's case, self service bar, or packaged. Packaged product is labeled as listed below: "WHOLE FOODS MARKET***RANCH DRESSING NO OIL ADDED***TOFU ( WATER, SOYBEANS, ISOLATED SOY PROTEIN, GLUCONOLACTONE & CALCIUM CHLORIDE), OAT MILK, LEMON JUICE, ONION, WHITE VINEGAR, DIJON MUSTARD ( DISTILLED VINEGAR, WATER, MUSTARD SEED, SALT, WHITE WINE, CITRIC ACID, TARTARIC ACID, SPICES, TURMERIC), NUTRITIONAL YEAST, BASIL, GARLIC, CILANTRO, GREEN ONION, DILL, PARSLEY, PEPPER, CRUSHED RED PEPPER. CONTAINS : SOY***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. RANCH ICEBERG SALAD WEDGE NO OIL ADDED | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Russian Coleslaw is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***RUSSIAN COLESLAW***CABBAGE, CARROTS, THOUSAND DRESSING ( CANOLA MAYONNAISE ( CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE), SWEET PICKLE RELISH ( CUCUMBERS, CRYSTALLIZED CANE JUICE, WATER, DISTILLED VINEGAR, SALT, DEHYDRATED PEPPERS, CALCIUM CHLORIDE, XANTHAN GUM, NATURAL SPICE FLAVORS, GUM ARABIC), SWEET THAI CHILI SAUCE ( SUGAR, WATER, CHILI, VINEGAR, GARLIC, SALT, GUAR GUM, CITRIC ACID), ONION, RED HOT SAUCE ( AGED CAYENNE PEPPERS, VINEGAR, WATER, SALT, GARLIC POWDER), LIQUID AMINOS ( FORMULATED SOY PROTEIN, WATER), PAPRIKA, KETCHUP ( TOMATO PUREE, EVAPORATED CANE JUICE, SUGAR, WHITE VINEGAR, SALT, ONION POWDER & SPICES). CONTAINS: EGG, SOY***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. RUSSIAN SALAD | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. SEASONAL SUCCOTASH | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | The Shrimp Salad Sandwich is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***SHRIMP SALAD SANDWICH***SHRIMP, CANOLA MAYONNAISE ( CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE), CELERY, ONIONS, CARROTS, PARSLEY, KOSHER SALT, PEPPER, SPINACH WRAP ( UNBLEACHED UNBROMATED ENRICHED WHEAT FLOUR ( WHEAT FLOUR, NIACIN (VITAMIN B3), REDUCED IRON, THIAMINE MONONITRATE (VITAMIN B1), RIBOFLAVIN (VITAMIN B2), FOLIC ACID ( VITAMIN B 9), MALTED BARLEY FLOUR), WATER, SUNFLOWER OIL, CONTAINS: 2% OR LESS OF: CULTURED WHEAT FLOUR ADDED WITH VINEGAR, SALT, LECITHIN, DRIED SPINACH POWDER, YEAST, GUAR GUM, LEAVENINGS ( SODIUM ACID PYROPHOSPHATE, SODIUM BICARBONATE, CORN STARCH, MONOCALCIUM PHOSPHATE), CITRIC ACID), GREENLEAF LETTUCE, TOMATO. CONTAINS: EGGS, SHELLFISH, WHEAT.***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. SHRIMP WITH SNOW PEAS | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. SOY & THE SEA | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. TEMPEH SALAD | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | The Thousand Island Chicken Salad Roll is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***1000 ISLAND CHICKEN SALAD ROLL 2 FOR 5***BREAD ( UNBLEACHED UNBROMATED WHEAT OR WHOLE WHEAT FLOUR, WATER, FLORIDA CRYSTALS SUGAR, PALM OIL, EGGS, NON FAT DRY MILK, ASCORBIC ACID, SALT, YEAST, CULTURED WHEAT FLOUR, SOY LECITHIN & NATURAL ENZYMES), CHICKEN ( CHICKEN, WATER, RICE STARCH, SALT), OR TURKEY, CAGE-FREE EGGS (EGGS, WATER, CITRIC ACID), CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE, CUCUMBERS, CRYSTALIZED CANE JUICE, WATER, DISTILLED VINEGAR, SALT, DEHYDRATED PEPPERS, CALCIUM CHLORIDE, XANTHAN GUM, NATURAL SPICE FLAVORS, GUM ARABIC, CALCIUM CHLORIDE, DEHYDRATED BELL PEPPERS, SPICES (CELERY SEED), NATURAL FLAVORS ( CASSIA, CLOVE), CITRIC ACID, ONION, AGED CAYENNE RED PEPPERS, GARLIC POWDER, LIQUID AMINOS ( FORMULATED SOY PROTEIN, WATER), PAPRIKA, KETCHUP ( TOMATO PUREE, EVAPORATED CANE JUICE, SUGAR, WHITE VINEGAR, SALT, ONION POWDER & SPICES), CAPERS ( CAPERS, VINEGAR SALT), GARLIC, EXTRA VIRGIN OLIVE OIL, DILL, CABBAGE, CARROTS, SUGAR, CHILI, SALT, GUAR GUM, CITRIC ACID), AGED CAYENNE RED PEPPERS, PAPRIKA CONTAINS: WHEAT, EGGS, MILK, SOY.***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The Thousand Island Chicken Salad Sandwich is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***THOUSAND ISLAND CHICKEN SALAD SANDWICH***CHICKEN ( CHICKEN, SEASONING ( SALT, GRANULATED ONIONS & GARLIC, WHITE PEPPER, BLACK PEPPER), THYME), OR TURKEY, CAGE-FREE EGGS (EGGS, WATER, CITRIC ACID), CABBAGE, CARROTS, THOUSAND ISLAND DRESSING ( CANOLA MAYONNAISE ( CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY MUSTARD, LEMON JUICE), SWEET PICKLE RELISH ( CUCUMBERS, CRYSTALLIZED CANE JUICE, WATER, DISTILLED VINEGAR, SALT, DEHYDRATED PEPPERS, CALCIUM CHLORIDE, XANTHAN GUM, NATURAL SPICE FLAVORS, GUM ARABIC), SWEET THAI CHILI SAUCE ( CUCUMBERS, SUGAR, VINEGAR, SEA SALT, XANTHAN GUM, CALCIUM CHLORIDE, DEHYDRATED BELL PEPPERS, SPICES ( CELERY SEED), NATURAL FLAVORS ( CASSIA, CLOVE), CITRIC ACID), ONION, RED HOT SAUCE ( AGED CAYENNE RED PEPPERS, VINEGAR, WATER, SALT, GARLIC POWDER), ....***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Conch Salad is labeled as listed below: "***SALAD CONCH***INGREDIENTS: GROUND CONCH, MOJO (GARLIC, ONION, GRAPEFRUIT JUICE (100% SQUEEZE D), OANGE JUICE (100% SQUEEZED) , LIME JUICE (100% PASTEURIZED ), ONION, EXTRA VIRGIN OLIVE OIL, CUMIN), BLACKENING SEASONING (SALT, SPICES, PAPRIKA, GARLIC, ONION POWDER ( CALCIUM STERATE ), SUGAR, CHILI POWDER ( CHILI PEPPER, SPICES, SALT, SILICON DIOXIDE, SOYBEAN OIL) , SUGAR, 100% PASTEURIZED LIME JUICE, FLORIDA BAY SEASONING ( SALT, SPICES, PAPRIKA ), SALT, TOMATO JUICE ( TOMATO CONCENTRATE (WATER, TOMATO PASTE ), SALT, VITAMIN C ( ASCORBIC ACID ), CUCUMBER, TOMATO, ONION, GREEN PEPPER, BLACK PEPPER, PARSLEY. CONTAINS: SHELLFISH, SOY.*** SELL BY: 08/08/12***NET WT 0.95 LB***550 BOWIE ST. AUSTIN, TX 78703***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. THOUSAND ISLAND SHRIMP SALAD | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. Thousand Island Surimi | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. Thousand Island Surimi Crab Salad Roll | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The Thousand Island Surimi Salad is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***THOUSAND ISLAND SURIMI SALAD***SURIMI ( FISH, PROTEIN ( POLLOCK AND/OR PACIFIC WHITING), WATER, SUGAR, WHEAT STARCH, EGG WHITE, POTATO STARCH....***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. THREE BEAN SALAD | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. TOFU JAPONAISE | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The Tuna With Cranberries Salad Sandwich is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***TUNA SALAD WITH CRANBERRIES (TUNA ( TUNA, WATER, VEGETABLE BROTH (CARROTS & PEAS), SALT), ONIONS....***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. Tuna with Sun-Dried Cranberries | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Food/Cosmetics | Gills Onions were used in this product. The Tuna With Sun-Dried Cranberries & Lemon is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***TUNA WITH SUN-DRIED CRANBERRIES AND LEMON*** TUNA ( TUNA, WATER, VEGETABLE BROTH (CARROTS & PEAS), SALT), ONIONS....***" | None | Class I | Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination. | Ron Stockman Whole Foods |
| Devices | GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. K061163: For Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ devices with Innova IVUS option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova IVUS Option: The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface, (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system. K091658: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. | System ID (As required) 910162015 AZ4001VA01 BH1000VA01 BY4033VA01 BY4020VA02 BG4549VA01 BG4009VA01 416480INNOVA2 HSRINNOVA1 82416070010 82416150007 82416210022 82416040046 CS1006VA05 EG1000VA01 M4198064 N4192939 M4166990 M4212443 HC1819XR10 HC5284XR39 542120XR02 HC5284XR38 83016862100448 835160028 IQ1165VA02 IE1100VA03 A5632421 A5102694 A5379605 A5320145 B5114298 A5360408 YV0370 YV0365 YV0364 YV0166 YV0369 YV0473 YV0480 YV0478 YV0475 YV0362 YV0510 YV0474 YV0481 YV0367 YV0477 YV0388 YV0466 YV0500 YV0463 YV0476 YV0464 YV0462 YV0400 YV0366 YV0501 YV0520 YV0363 YV0555 YV0472 YV0471 YV0470 YV0469 YV0468 YV0467 KW1098VA01 KW1098VA02 KW1011VA02 LB1331VA01 LY1086VA01 834160006 834160005 834160004 INNOVA2948687 PL1804VA01 PER18124 RO1095VA01 RU3427VA01 RU2741VA04 RU3847VA01 RU3883VA01 NA SA2253VA01 SA2236VA01 847160005 847160006 850060744 850060739 MEX68922 853060209 853060201 853060200 853060198 853060202 856160010 AE1225VA01 00234VAS02 00095VAS08 05448VAS01 00440VAS04 10086VAS07 10307VAS01 00243VAS02 00026VAS01 256HHCIB1 205877CCL3 480512BP 8184093131 6263973131 415206IBP1X53 3108252121A 3108252121B 909LLUMC2121 661949INNOVA3 650493BIPL 510428BIPL 619543INNOVABP CHLDRNCL1 303436LCLP 303425CL2 2036882121 FHORLEP4 561548BIP 561495DLBIP FHORLEP5 FHORL3131 904202WCL1 561881BP1 561881BP2 808547QCV4 319272EP 208227INNOVA31 630856H3131 630933INVLAB4 309655FSP4A 773RES3131BP 309655FSP2B 219326EP1 812238UNBPL 317338PV4 317338CL4BP 2197383131 2192632121 2198362121 913541OP3131 316268BIPLANE 504842OMC3131 504842OMCEP2 504842OMCEP1 504897INNOVA2 985867INNOVA31 617636IN2121 857307IN12121 857307IN22121 617525IN13131 857307IN32121 410614CV2 410614CV1 4105502121 410740CV 3018912121 202782LABA 301295EP 301295CATH 616392BP 507385INN3131 612273INNOVA3 816698CP3131 816932SL3131 704355RM7 704355P2121 603650EP1 973971EP3 973972LAB3 7327762121 7323213131 505887CL1 7028533131 718579INNOVABP 516562INNOVA1 718226BP1 COR373252 COR373301 COR373295 ORMCIR2 518262BP1 5135843131 541743CL5 503OHSUCV4 503OHSUCV3 541743CL2 541382BP 570824BP1 215576INNOVA2 LVINOV6 610526LAB3 814877BP 215662INNOVA3 412623H 610954BP1 864512EPBP 843692GSBPEP 615284ANG2 615222BIH 615222BIG 615769SP1 956632INN3131 281637SL3131 832522MW3131 903CSM2121 817465AR3131 361857CATH2 VAD2121 BMANGIO 936539CL4 936WH2121 214590EP2121 BMEP 713794LAB8 832355LAB4 713794LAB11 281440BP31 210617VACATH1 MCDEP 801532LCA 540776LGVAS2 276258INV3131 434654CATH2121 253627INNOVA5 206598UWBP 253403CL4 509474BIP 509473RM1 4146492121 4144473131 ECXV1402B 304526INNOVABP YE1002VA01 | Class II | GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover. | GE Healthcare, LLC |
| Devices | Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: " Patient registration " Order entry and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards and controls recording " Test order result inquiry and reporting Organism susceptibility and epidemiology records " Microbiology culture direct examination and observation recording " Outreach clients, specimens, and results " Client-specific reporting capabilities " Inbound client service request tracking " Historical data Clients that use the Sunquest Blood Bank system should refer to the intended use statement found in the Blood Bank System Overview Users Guide. | Version versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 | Class II | Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is used and the "Event merge across patients" option is used, a receiving system (for example a HIS or CoPath system) may interpret the event merge as a full patient merge. This occurs because a trigger from the Laboratory system for the event merge across patients may be formatted exactly the same as the patient-to-patient merge trigger. This may also occur if the application interfacing code has not been modified to process the event merge across patients trigger. | Sunquest Information Systems, Inc. |
| Devices | Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags. | Catalog No. 300316A (Lot Nos. - NGVJ1108, NGVJ1712, NGVJ1713, NGVJ1105, NGVJ1714) Catalog No. 898316 (Lot Nos. NGVJ1614, NGVJ1615, NGVJ1616, NGVJ1617) Catalog No. 897414 (Lot No. NGVJ1705) Catalog No. 907618 (Lot No. NGVJ1757) Catalog No. 907600 (Lot No. NGVJ1764) | Class II | Incomplete seal on sterile packages of product. | C.R. Bard, Inc., Urological Division |
| Food/Cosmetics | Crown Program BK Fresh Apple Slices, 2 oz On or before August 13; no upc code | On or before August 13; no upc code | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Hannaford Apples & Caramel Snack Pack Net Wt. 4 oz (113g) Distributed By: Hannaford Bros. Co., Scarborough, ME 04074 1-800-213-9040. www.hannaford.com On or before August 18 UPC 4126817191 | On or before August 18 UPC 4126817191 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Hannaford Apple, Granola, & Yogurt Snack Pac, Net Wt. 4.3 oz (122g), Distributed by Hannaford Bros. Co., Scarborough, ME 04074 10-800-213-9040 www.hannaford.com. On or before August 18 UPC 4126817195 | On or before August 18 UPC 4126817195 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | McDonalds M Apple Slices Net Wt 1.2 oz (34g) On or before August 19; no upc code | On or before August 19; no upc code | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | McDonalds M Diced Apples Net Wt. 0.02 oz (26g) On or before August 19; no upc code | On or before August 19; no upc code | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | McDonalds M fruit & walnut snack with vanilla lowfat yogurt Net Wt 5.75 OZ (163g) On or before August 20; no upc code | On or before August 20; no upc code | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Ready Pac Bistro Apple Bleu Pecan Salad Net Wt. 4.75 OZ (135g) Dist. by Ready Pac Foods, Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 12; UPC 7774529497 | On or before August 12; UPC 7774529497 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Ready Pac fruit frenzy Net Wt. 32 OZ (2 LB) 907 g Distributed by Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-782 www.readypac.com On or before August 18; UPC 7774523086 | On or before August 18; UPC 7774523086 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Ready Pac fruit tray bien Net Wt. 32 OZ (2 LB) 907 g Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 18; UPC 7774521606 | On or before August 18; UPC 7774521606 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Ready Pac Ready Snax Apples & Cheese with Caramel Dip Snack Pac Net Wt. 4 OZ (113g) Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 readypac.com On or before August 18; UPC 7774523896 | On or before August 18; UPC 7774523896 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Ready Pac Ready Snax Apples, Celery, Raisins with Peanut Butter Snack Pac Net Wt 4 oz (113g) Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 18; UPC 7774523897 | On or before August 18; UPC 7774523897 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Ready Pac Ready Snax Apples, Granola, & Yogurt Snack Pac Net Wt 4.3 OZ. Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 18; UPC 7774523089 | On or before August 18; UPC 7774523089 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Ready Pac super fruit blend Net Wt 6 oz (170g) Distributed By Ready Pac Foods Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 17; UPC 7774523076 | On or before August 17; UPC 7774523076 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Ready Pac super fruit medley Net Wt 10.5 OZ (298g) Dist. by Ready Pac Foods, Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 16; UPC 7774523746 | On or before August 16; UPC 7774523746 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Ready Pac Sweet Sunshine Platter Net Wt 37 OZ )2 LB 5 OZ) 1.05 Kg Dist. by Ready Pac Foods, Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 16; UPC 7774524204 | On or before August 16; UPC 7774524204 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Safeway farms Complete Apple, Blue Cheese & Pecan Total Net Wt. 8.75 OZ (248g) Salad & Toppings 6.75 OZ (191g) Dressing 2 OZ (!.83 FL OZ) 54 mL Distributed by Safeway Inc. PO Box 90 Pleasonton, CA 94506-0009 1-800-SAFEWAY/www.safeway.com On or before August 18; UPC 2113033680 | On or before August 16; UPC 7774524204 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Wawa apple caramel dipper Net Wt 6.7 OZ (191g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 16; UPC 261900394 | On or before August 16; UPC 261900394 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Wawa apple peanut butter dipper Net Wt. 6.5 OZ (183g) Distributed by: Wawa, Inc Wawa, PA 19063 wawa.com On or before August 15; UPC 261900268 | On or before August 15; UPC 261900268 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Wawa apple slices Net Wt 3.5 OZ (99g) Distributed by: Wawa Inc. Wawa, PA 19063 wawa.com On or before August 16; UPC 261902232 | On or before August 16; UPC 261902232 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Wawa baby carrots Net Wt 3 oz (85g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 16; UPC 2619102517 | 1) Wawa baby carrots Net Wt 3 oz (85g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 16; UPC 2619102517 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Wawa Chicken salad Snack Net Wt. 6.7 oz Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 12; UPC 261902760 | On or before August 12; UPC 261902760 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | 21) Wawa Chicken salad sandwich Net Wt. 7.8 OZ (221g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 10; UPC 261905670 | On or before August 10; UPC 261905670 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | ) Wawa fruit & cheese Net Wt 6 OZ Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 11; UPC 261902567 | On or before August 11; UPC 261902567 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Wawa protein power pack Net Wt 7.8 OZ Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 11; UPC 261902565 | On or before August 11; UPC 261902565 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Wawa red grapes Net Wt 3 OZ (85g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 13; UPC 2619102518 | Wawa red grapes Net Wt 3 OZ (85g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 13; UPC 2619102518 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Wawa turkey & cheese sandwich Net Wt 7.7 OZ (219g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 10; UPC 261905622 | On or before August 10; UPC 261905622 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Wegmans Apples, Celery, Raisins, & Peanut Butter Net Wt 4 oz. (113g) Distributed by: Wegmans Food Markets, Inc. Rochester, NY 14603 On or before August 18; UPC 7789026744 | On or before August 18; UPC 7789026744 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Wegmans Apples, Cheese & Caramel Dip, 4 OZ (113g) Distributed by: Wegmans Foods Markets, Inc. Rochester, NY 14603 On or before August 15; UPC 7789026743 | On or before August 15; UPC 7789026743 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Food/Cosmetics | Wegmans Apples, Granola, & Low Fat Vanilla Yogurt, 4.3 OZ (122g) Distributed by: Wegmans Foods Markets, Inc. Rochester, NY 14603 On or before August 18; UPC 7789026737 | On or before August 18; UPC 7789026737 | Class I | The products are contaminated with Listeria monocytogenes. | Missa Bay, LLC |
| Devices | Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved Scissors are intended for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery. This accessory is to be used with the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, 12000, ISSOQO). | Model No. 400180-12 Lot No: M10120601 M10120430 M10120329 M10120312 M10111214 M10120516 M10120426 M10120321 M10120208 M10111208 M10120510 M10120419 M10120317 M10120207 M10111201 M10120507 M10120413 M10120315 M10120130 M10111028 | Class II | There is potential for the sterility of the product to be compromised. | Intuitive Surgical, Inc. |
| Devices | Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1 - degenerative disc disease, 2 - spondylolisthesis, 3 - trauma, 4 - spinal stenosis, 5 - deformities or curvatures, 6 - tumor, 7 - pseudoarthrosis, and 8 - failed previous fusion. | All distributed lots and serial numbers | Class II | There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert preventing the screw head from locking down to the bone screw. | Aesculap Implant Systems LLC |
| Devices | Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron UMPC which is a bedside device that enables automatic collection of vital signs data that can connect to the hospital network through a wired Ethernet connection or via a standard 802.11 b/g/n wireless network. | Serial Numbers TS9801371 -TS9801650; TS9900670 - TS9900679; TS9B00413 - TS9B00722; TS9B01753 - TS9B02041; TSA301587 - TSA302186; TSA600246 - TSA600845 TSA801222 - TSA801821; TSAB00031 - TSAB00629; TSB300410 - TSB300912; TSB302698 - TSB303201; TSB401570 - TSB402012; TSB500633 - TSB501136; TSB502359 - TSB502861; TSB600767 - TSB601270; TSB700368 - TSB700871; TSB801147 - TSB803555; TSB902081 - TSB902585; TSBA03569 - TSBA03595; TSBB00027 - TSBB00537; TSBC00200 - TSBC01321; TSC100319 - TSC101318; TSC101972 - TSC103113; TSC301294 - TSC301299; TSC301389 - TSC303425; TSC401639 - TSC401995; TSC402020 - TSC402087; TSC402136 - TSC402346 | Class II | Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron | Capsule Tech Inc. |
| Devices | CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep | 19207-1004 | Class II | The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications. | Custom Medical Specialties, Inc. |
| Devices | CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep | 16480-0908, 20976-1008, 21283-1009 | Class II | The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications. | Custom Medical Specialties, Inc. |
| Devices | CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep | 20179-1006 | Class II | The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications. | Custom Medical Specialties, Inc. |
| Devices | CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution | 14327-0902, 19929-1006 | Class II | The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications. | Custom Medical Specialties, Inc. |
| Food/Cosmetics | Meijer Brand Mushrooms, imported from The Netherlands Stems & Pieces, DR WT 4-oz and 8-oz sizes/Net Wt. 6.5-oz and 13.25-oz, UPC 7-1373337545-0 and UPC 7-1373337544-3 | All lots | Class III | The sodium in the product is above the declared value of the sodium stated on the label. | Meijer Distribution, Inc |
| Devices | The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. | Model #: P6500, S/N 400000 through 406294 | Class II | The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property. | Steris Corporation |
| Devices | Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device. | The letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the letter. | Class II | Reports of leaking during filling and administration. | Hospira, Inc. |
| Devices | Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Lot Numbers: 8361, 8525, 8894,8930, 8975, 9167, 9169, 10220, 10313, 10717, 11547 | Class II | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | Omni Life Science |
| Devices | Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Lot Numbers: 8362, 8524, 8853, 8988, 8992, 9021, 9040, 9152, 9883, 9885, 10221, 10318, 10726, 11478 | Class II | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | Omni Life Science |
| Devices | Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Lot Numbers: 8363, 8715, 8864, 8876, 8982, 9007, 9013, 9123, 9168, 10317 | Class II | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | Omni Life Science |
| Devices | Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Lot Numbers: 8395,8823, 8929, 8969, 8984, 9166, 10319, 10740, 11703 | Class II | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | Omni Life Science |
| Devices | Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Lot Numbers: 8396, 8989, 9225, 10316, 10713, 11571, 11669 | Class II | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | Omni Life Science |
| Devices | Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement. | Lot Numbers: 10723, 10763, 10824 | Class II | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | Omni Life Science |
| Veterinary | Frozen mice in ziplock bags | There is no code information. The package shows the type of mice and the quantity. | Class II | The firm initiated a voluntary recall of frozen mice because of possible human exposure to Lymphocytic Choriomenengitis Virus from handling the mice. | Steve Pritchett Farms LLC |
| Devices | Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated. | 152599 and 152678 | Class II | Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex. | Elekta, Inc. |
| Food/Cosmetics | Thai Farmer Brand Preserved Star Gooseberry, NET WT 7.0 OZ. Packaged 30 per case. Product labeling reads in part:"***THAI FARMER BRAND PRESERVED STAR GOOSEBERRY*** DISTRIBUTED BY: T.F. FOODS, INC. PARAMOUNT, CA 90723***NET WT. 7.0 OZ***PRODUCT OF THAILAND***". | Product not coded. Production date is May 2, 2011. | Class II | Products recalled due to undeclared FD&C Yellow # 6. | T.F. Foods Incorporated |
| Veterinary | "Sirius Dog Treats". Bone-shaped treats packaged 10 each in a cellophane package | "126", "136", "143" and "150". These are the julian dates that the dough was made, baked and packaged. | Class II | The wheat germ used by the firm to make their products was recalled by the wheat germ manufacturer because it was potentially contaminated with metal fragments approximately 0.5mm in diameter and 3-15mm in length. The contamination occurred at the raw ingredient manufacturer. | Breadfarm |
| Devices | STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model. | Product Code: 10113 | Class III | Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing. | Advanced Sterilization Products |
| Devices | STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model. | Product Code: 10133 | Class III | Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing. | Advanced Sterilization Products |
| Devices | Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference. | Part #-Lot # (s): 762.010L-110738; 762.013L-110738; 762.017L-60611, 90611, and 512171; 762.019L-60611, 90611, 100308, 1261901, and 20121901; 762.021L-60611, 90611, 100308, 110106, 20122101, and 20122102; 762.023L- 90611, 100209, 100218, 00706, 10709, 20122301, and 20122302; 762.025L-90611, 100218, 110106, 20122501, and 20122502; 762.027L-60611, 90611, 100706, and 20122071; 762.029L-90611, 1262901, and 90611; 762.031L-1263101; 762.033L-90611, 91002, and 1263301; 762.041L-90611 and 1264101; 762.043L-90611 and 1264301; 762.045L-90611; 762.047L-90611; 762.049L-90611; 762.051L-90611 and 512511; 762.053L-90611; 762.090L-90611; 762.090L-2.0-100206 and 100342; 762.090L-2.5-100206; 762.159L-110505; 762.237L-91002; 762.243L-91018; 762.270L-91018; 762.290L-91018; 762.731L-91018; 762.735L-91002; 762.767L-91018; and 762.790L-91018. | Class II | The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation. | Lucero Medical LLC |
| Veterinary | Product is an aqueous Black/Carpenter Ant, veterinary allergenic extract in liquid form. Product is viled in 10 mL Type 1 glass vials, stoppered with latex stoppers and sealed with a 13 mm aluminum crimped cap. | Lot # 200794 | Class III | Mislabeled vials | Greer Laboratories Inc |
| Devices | Optima XR220amx Mobile general purpose radiographic imaging of the human head and body. | Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6. | Class II | Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed. | GE Healthcare, LLC |
| Devices | Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body. | Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6. | Class II | Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed. | GE Healthcare, LLC |
| Food/Cosmetics | Meal Replacement product is labeled in part: "***The Perfect Shake***All of the Best***None of the Rest***foru***Dietary supplement***Net wt. 20 oz (1 lb 4 oz) (564 g)***A well balanced blend of old-world plant nutrition.***What's in The Perfect Shake supplement? All of the best, and none of the rest, in amounts that are the right balance for you.***More than just the best ingredients, The perfect Shake supplement is made from the optimal ratio of the right ingredients, scientifically designed to supplement a healthy diet and use along with your weight management program.**The Perfect Shake supplement is as much about what it doesn't contain as what it does. There are no animal proteins (it's vegan). No whey, soy or casein. No ingredients produced using biotechnology. No glutens. No artificial sweeteners like sucralose or aspartame.***Maintaining your ideal energy levels and supporting your weight management goals shouldn't be a challenge; it should be easy, natural, and something anyone can do.***Try The Perfect Shake Supplement for 30 days. If you don't love it, return the empty container for a full refund.***All of the Best***Ancient Grain Blend***Amaranth, Sorghum and Brown Rice***Richest sources of nutrients among grains***Metabolic Support Blend***Use as part of your diet to help promote healthy blood sugar levels***Promotes healthy metabolism* ***SuperFood Blend***With superfoods like spinach and carrot powders***Lycopene - the powerful anti-oxidant***Digestive Blend***Dietary fiber to support your digestive system***Guar gum to provide a gentle laxative***Beneficial bacteria to promote digestive health* ***Natural Flavoring and Sweeteners***NuStevia - sweeter than sugar without the unwanted effects***Natural vanilla flavor***None of the Rest***whole milk***gluten***lactose***processed sugar***fructose***casein protein***processed sugar***fructose***casein protein***synthetics***food dyes***artificial coloring***ingredients produced using biotechnology***artificial sweeteners***artificial flavorings***Directions for use: For adults 18 years and older, mix one full scoop with water or skim milk. Not for use by individuals under the age of 18.***Supplement Facts Serving Size 1oz***Servings Per Container: 30***Ancient Grain Blend 10g***Brown Rice, Amaranth, Sorghum***Metabolic Support Blend 346mg***Irvingia Gabonesis 4:1, Guarana PE 12% Chromium Picolinate, Slippery Elm Bark Spirulina Powder, Vita Choline, Mucuana Pruiens 25% To 40%, Noni PE 4:1, PPQ***SuperFood Blend 195mg***Spinach Powder, Carrot Powder, Pascalite Powder Horsetail Powder Ext. 7%, Lycopene 5%***Digestive Blend 5g***Fibers (Maltodextrin), UltraSmooth (Tic Gum) Guar Gun, Fungal Protease 100,000HUTG Lactobacillus Acidophilus 10 Billion***Other Ingredients: Natural Vanilla Flavor, NuStevia***This product is derived from natural ingredients and therefore color may vary from lot to lot, and some ingredients may not dissolve as rapidly as other natural ingredients.***Keep lid tightly closed and in a dark, cool place. Keep out of reach of children. This product is sold by weight, not by volume. Settling of contents may occur during shipping and handling.***Questions? 1-888-488-9493***Manufactured for foru international, inc. 1231 Greenway Drive, Ste. 200 Irving Texas 75038***" The product is in white plastic bottles with Black Top. Product is packaged 12 bottles per case. Product Form: Powder. Dosage: 1 Scoop (16.6g) Product Description: Cream color powder blend, somewhat vanilla scent. Product use: Intended use as meal replacement. | Lot R2-981-12. Exp 07/14 | Class II | Atlas Operations, Inc is recalling Meal Replacement foru Dietary Supplement, Lot R2-981-12, Exp. Date: 7/14 for possible microbial contamination. | Atlas Operations, Inc. |
| Devices | BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional. | Lot#1008419 | Class III | Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date. | Helix Medical LLC |
| Devices | Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system | Model number 5756130 -- serial numbers 6076, 6078, 6080, 6081, and 6082. | Class II | Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and the entire table assembly may fall on the floor. | Siemens Medical Solutions USA, Inc |
| Devices | Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system | Model number 10273100 - serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054 | Class II | During regular product monitoring, firm became aware of a potential issue with the Mobilett Mira system, (serial numbers 1034, 1038, 1041, 1042, 1043, 1050, 1053, and 1054. During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization. There is no risk of the system tipping over or collapsing on the floor, however the system may tilt to the floor on one side. | Siemens Medical Solutions USA, Inc |
| Devices | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. | All serial numbers. | Class II | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedure. If the delay occurs after a patient has already been anesthetized, the resulting delay could extend the patient's time under anesthesia if time is required to troubleshoot the system or if it is rendered inoperable. Models Ref 8253200 (Response) and Ref 8253410 (Neuro) were distributed in the US and Models Ref 8253200 (Response), Ref 8253210 (Pulse) and 8253410 (Neuro) were distributed internationally. | Medtronic Xomed, Inc. |
| Devices | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. | 8253410 (Neuro). All Serial Numbers. | Class II | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedure. If the delay occurs after a patient has already been anesthetized, the resulting delay could extend the patient's time under anesthesia if time is required to troubleshoot the system or if it is rendered inoperable. Models Ref 8253200 (Response) and Ref 8253410 (Neuro) were distributed in the US and Models Ref 8253200 (Response), Ref 8253210 (Pulse) and 8253410 (Neuro) were distributed internationally. | Medtronic Xomed, Inc. |
| Devices | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" Cord is labeled in part: "***Ref.***Mfg Date***Sn***" The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. | 8253210 (Pulse). Serial Numbers 00004, 00009, 00010, 00013, 00014, 00015, 00017 (International Consignees only) | Class II | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedure. If the delay occurs after a patient has already been anesthetized, the resulting delay could extend the patient's time under anesthesia if time is required to troubleshoot the system or if it is rendered inoperable. Models Ref 8253200 (Response) and Ref 8253410 (Neuro) were distributed in the US and Models Ref 8253200 (Response), Ref 8253210 (Pulse) and 8253410 (Neuro) were distributed internationally. | Medtronic Xomed, Inc. |
| Devices | Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology. | All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02 | Class II | The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself. | Volcano Corporation |
-
