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U.S. Department of Health and Human Services

Medical Device Recalls

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RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by ortho... 2 12/18/2014 Mako Surgical Corporation
Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027. In ... 2 03/03/2010 Medtronic Navigation, Inc
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: ... 2 10/11/2018 MicroPort Orthopedics Inc.
1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filter... 1 12/17/2013 Nephros Inc
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : ... 1 12/17/2013 Nephros Inc
EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit cont... 2 09/10/2009 Oak Tree International Holdings, LLC, Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Ac... 2 09/05/2019 OMNIlife science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup ... 2 09/05/2019 OMNIlife science Inc.
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup ... 2 09/05/2019 OMNIlife science Inc.
OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-1392... 2 07/25/2018 OMNIlife science Inc.
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Pr... 2 08/21/2015 Omnilife Science Inc.
Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty proce... 2 08/17/2014 Ortho Development Corporation
U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver ... 2 01/13/2012 Ortho Development Corporation
VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Id... 3 11/02/2015 Ortho-Clinical Diagnostics
VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Prod... 2 11/15/2013 Ortho-Clinical Diagnostics
U2 Acetabular cup, Ti beads porous coated, ®44mm U2 Acetabular cup, Ti beads porous coated, ®46mm ... 2 05/24/2013 Orthopedic Alliance LLC
OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Ar... 2 10/04/2011 Osteomed, Lp
NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. Th... 2 01/16/2013 Perkinelmer
NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)0643814... 2 05/04/2018 PerkinElmer Life and Analytical Sciences, Wallac, OY
Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost El... 2 06/20/2012 Philips Healthcare Inc.
MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product ... 2 02/08/2012 Philips Healthcare Inc.
Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037 Product Usage:... 2 02/02/2012 Philips Healthcare Inc.
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 70803... 2 03/31/2016 Philips Medical Systems, Inc.
MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universa... 2 03/23/2019 Philips North America, LLC
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a mu... 2 03/23/2019 Philips North America, LLC
Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 0... 2 08/31/2012 Princeton Biomeditech Corp
Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use is to val... 2 01/17/2009 Quantimetrix Corporation
Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsa... 2 12/23/2015 Rainbow Specialty & Health Products
Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 includes the R... 2 08/11/2009 Roche Diagnostics Corp.
Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137001, 05177... 2 08/11/2009 Roche Diagnostics Corp.
Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 048377... 2 08/11/2009 Roche Diagnostics Corp.
Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 includes the R... 2 08/11/2009 Roche Diagnostics Corp.
Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 includes the ... 2 08/11/2009 Roche Diagnostics Corp.
Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models... 2 08/11/2009 Roche Diagnostics Corp.
Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.;... 2 10/09/2008 Roche Diagnostics Corp.
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminoph... 2 04/25/2018 Roche Diagnostics Corporation
Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322, Roche Dia... 2 03/16/2011 Roche Diagnostics Operations, Inc.
Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics ... 2 03/16/2011 Roche Diagnostics Operations, Inc.
ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagno... 2 09/08/2010 Roche Diagnostics Operations, Inc.
Synvisc-One ® (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous h... 2 02/14/2018 Sanofi Genzyme
Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood lancet) 2 10/14/2008 Sarstedt Inc
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for t... 2 06/27/2012 Sekisui Diagnostics Llc
Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: ... 2 03/14/2016 Sekisui Diagnostics P.E.I. Inc.
Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix® Positive and Negative Control Strip... 3 01/04/2013 Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix® Positive and Neg... 3 01/04/2013 Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix® Positive a... 2 01/04/2013 Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix® Positive and... 3 01/04/2013 Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 C... 3 01/04/2013 Siemens Healthcare Diagnostics Inc
Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 50... 3 01/04/2013 Siemens Healthcare Diagnostics Inc
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) ... 3 01/04/2013 Siemens Healthcare Diagnostics Inc
Syva® EMIT® II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440 3 05/10/2018 Siemens Healthcare Diagnostics, Inc.
Syva® EMIT® II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483 3 05/10/2018 Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determinatio... 2 08/19/2015 Siemens Healthcare Diagnostics, Inc.
Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM... 2 10/22/2014 Signal Medical Corporation
Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are ... 2 03/06/2018 Signature Orthopedics Pty Limited
REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE... 2 12/26/2013 Smith & Nephew Inc
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF ... 2 08/08/2013 Smith & Nephew Inc
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF ... 2 08/08/2013 Smith & Nephew Inc
ACETABULAR PIN, REF 71366301, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orth... 2 06/06/2012 Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, Q... 2 04/22/2011 Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, Q... 2 04/22/2011 Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 36 MM O.D. 52 MM O.D., REF 71338952, STERILE R, Q... 2 04/22/2011 Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, Q... 2 04/22/2011 Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, Q... 2 04/22/2011 Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX® FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE R, Q... 2 04/22/2011 Smith & Nephew Inc
R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339166, STERIL... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 28 MM I.D., 64 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339164, STERILE E... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 28 MM I.D., 62 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339162, STERILE E... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339160, STERILE E... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 22 MM I.D., 58 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339158, STERILE E... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339156, STERILE E... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339154, STERILE E... 2 10/18/2010 Smith & Nephew Inc
R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339152, STERILE E... 2 10/18/2010 Smith & Nephew Inc
Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for... 2 09/24/2009 Smith & Nephew Inc
Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Comp... 2 04/21/2009 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant c... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant ... 2 10/25/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 58 mm cup Ref.: 74120158 2 06/07/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156 2 06/07/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 50 mm cup Ref.: 74120150 2 06/07/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146 2 06/07/2007 Smith & Nephew Inc
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 60 mm cup Ref.: 74120160 2 06/07/2007 Smith & Nephew Inc
BRAND: SKIN-PREP - Pouch Labeling and Box / Carton Labeling ***smith&nephew ***#420400***... 2 07/06/2011 Smith & Nephew Inc.
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and ... 2 08/10/2020 Smith & Nephew, Inc.
Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 ... 2 05/21/2018 Smith & Nephew, Inc.
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44... 2 09/10/2015 Smith & Nephew, Inc.

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
 
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