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U.S. Department of Health and Human Services

Medical Device Recalls
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Pacemaker, COPM11B; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Shoulder, SESH18I; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Nasal Sinus Pack, MTSN26B; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
ENT, COEN27N; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Cath Lab Pack, CECL02P; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Vaginal Delivery, ASDV25B; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Hand Pack, AKHD97C; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Neuro Vascular, ANKV91A; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
IR Procedure Pack, CEAT19W; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Paracentesis Thoracente, SLPT76H; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
PACEMAKER PACK, SLCV01J; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Endovascular AAA Pack, ESED52B; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Endovascular AAA Pack, ESED52B; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Arthroscopy Pack, MSKA45A; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Open Shoulder, LWOS39L; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Day Surgery General Pack, FHGE18T; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
Cysto, FTCY03L; Medical convenience kit 2 09/24/2024 American Contract Systems, Inc.
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5 2 09/24/2024 Centinel Spine, Inc.
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5 2 09/24/2024 Centinel Spine, Inc.
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01 2 09/24/2024 Waldemar Link GmbH & Co. KG (Corp. Hq.)
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software 2 09/24/2024 Siemens Medical Solutions USA, Inc.
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.... 2 09/24/2024 Siemens Medical Solutions USA, Inc.
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUS... 2 09/24/2024 Siemens Medical Solutions USA, Inc.
Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123 2 09/24/2024 Karl Storz Endoscopy
Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123 2 09/24/2024 Karl Storz Endoscopy
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123 2 09/24/2024 Karl Storz Endoscopy
Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123 2 09/24/2024 Karl Storz Endoscopy
Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123 2 09/24/2024 Karl Storz Endoscopy
Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123 2 09/24/2024 Karl Storz Endoscopy
Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123 2 09/24/2024 Karl Storz Endoscopy
Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123 2 09/24/2024 Karl Storz Endoscopy
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (... 2 09/24/2024 Becton Dickinson & Co.
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibili... 2 09/24/2024 Becton Dickinson & Co.
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system. 2 09/24/2024 GE Healthcare
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, ... 2 09/23/2024 Microcare Medical
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anteri... 2 09/23/2024 Stryker Spine
GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared h... 2 09/20/2024 Wipro GE Healthcare Private Ltd.
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M... 2 09/20/2024 Wipro GE Healthcare Private Ltd.
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N 1 09/20/2024 Smiths Medical ASD Inc.
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N 1 09/20/2024 Smiths Medical ASD Inc.
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-158... 2 09/20/2024 Argon Medical Devices, Inc
Custom Procedure Kit, REF: K12T-11077 2 09/20/2024 Merit Medical Systems, Inc.
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) 2 09/20/2024 Merit Medical Systems, Inc.
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectrosco... 2 09/20/2024 Philips North America Llc
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, sp... 2 09/20/2024 Philips North America Llc
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional imag... 2 09/20/2024 Philips North America Llc
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, sp... 2 09/20/2024 Philips North America Llc
MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/... 2 09/20/2024 Philips North America Llc
MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/... 2 09/20/2024 Philips North America Llc
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic im... 2 09/20/2024 Philips North America Llc
Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic im... 2 09/20/2024 Philips North America Llc
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images ... 2 09/20/2024 Philips North America Llc
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images... 2 09/20/2024 Philips North America Llc
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic ima... 2 09/20/2024 Philips North America Llc
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic ... 2 09/20/2024 Philips North America Llc
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic... 2 09/20/2024 Philips North America Llc
BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN20... 2 09/20/2024 Bard Peripheral Vascular Inc
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the qu... 2 09/20/2024 Roche Diagnostics Operations, Inc.
Stainless Steel Sims Uterine Sound, Part Number 64-601 2 09/20/2024 CooperSurgical, Inc.
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 2 09/20/2024 CooperSurgical, Inc.
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and def... 1 09/20/2024 Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and def... 1 09/20/2024 Datascope Corp.
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and def... 1 09/20/2024 Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and def... 1 09/20/2024 Datascope Corp.
VariSoft Infusion Set, Single Use. 2 09/19/2024 Unomedical A/S
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit ... 2 09/19/2024 Beckman Coulter, Inc.
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodi... 2 09/19/2024 B Braun Medical Inc
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during hae... 2 09/19/2024 B Braun Medical Inc
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haem... 2 09/19/2024 B Braun Medical Inc
STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a h... 2 09/19/2024 B Braun Medical Inc
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodia... 2 09/19/2024 B Braun Medical Inc
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodia... 2 09/19/2024 B Braun Medical Inc
STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a h... 2 09/19/2024 B Braun Medical Inc
Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid,... 2 09/19/2024 Safeguard US Operating LLC
HAWK Warming Grid, Item Number: 59-300 2 09/19/2024 Safeguard US Operating LLC
HAWK Advanced Hypothermia Management Set, Item Number: 59-320 2 09/19/2024 Safeguard US Operating LLC
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compound... 1 09/19/2024 Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compoun... 1 09/19/2024 Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding ... 1 09/19/2024 Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical comp... 1 09/19/2024 Baxter Healthcare Corporation
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener 2 09/19/2024 Smith & Nephew, Inc.
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener 2 09/19/2024 Smith & Nephew, Inc.
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 2 09/19/2024 Cypress Medical Products LLC
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008 2 09/19/2024 Cypress Medical Products LLC
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B1... 2 09/18/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 7... 2 09/18/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Dete... 2 09/18/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/... 2 09/18/2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
ADVIA Chemistry Microalbumin_2 (®ALB_2) -For in vitro diagnostic use in the quantitative measurement... 2 09/18/2024 Siemens Healthcare Diagnostics, Inc.
Atellica CH Microalbumin_2 (®ALB_2)-For in vitro diagnostic use in the quantitative measurement of m... 2 09/18/2024 Siemens Healthcare Diagnostics, Inc.
BiomarC EX Fiducial Marker System, Catalog Number 040165 3 09/17/2024 Carbon Medical Technologies, Inc.
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatm... 2 09/17/2024 Btt Health Gmbh
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; ... 2 09/17/2024 GE Healthcare
1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. ... 2 09/17/2024 UNIMAX MEDICAL SYSTEMS INC
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009 2 09/17/2024 ROi CPS LLC
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an in... 2 09/17/2024 Innovasis, Inc
ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanic... 2 09/17/2024 MICROVENTION INC.
General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson... 2 09/16/2024 Cypress Medical Products LLC

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