Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,907 FDA device recalls in 2015.

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DateProductReasonClassFirm
Apr 22, 2015 Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Laparotomy Tray, Kit number PSS1538 convenience custom kits used for gener... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Hall SAP, Kit number SRK1031(A convenience custom kits used for general surg... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit contain... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, P... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Universal Pack, Kit number AMS2036 convenience custom kits used for genera... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom k... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Mok Eye Pack, Kit number PSS2640 convenience custom kits used for genera... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Face Pack, Kit number AMS3641 convenience custom kits used for general sur... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical k... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, P... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit co... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical ... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Robotic Pack, Kit number AMS4389 convenience custom kits used for general ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Major Breast Pack, Kit number AMS3409 convenience custom kits used for gener... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit contai... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit conta... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for gene... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit ... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom k... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom kit were recalled... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Student Pack-NS, Kit number PSS2788 convenience custom kits used for gener... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designe... GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of th... Class II GE Healthcare
Apr 22, 2015 regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical k... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Transvaginal Pack, Kit number CMP1767 convenience custom kits used for gen... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit conta... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - sur... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenie... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS18... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for gen... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical ... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit ... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Major Kit, Kit number PHC1307(A convenience custom kits used for general sur... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical ki... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Set Up Pack, Kit number PSS3574(A convenience custom kits used for general... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit co... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Minor Lap Pack, Kit number AMS2624 convenience custom kits used for genera... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Foot Pack, Kit number AMS3637 convenience custom kits used for general surge... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit co... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custo... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Philips GoSafe Communicator 7000L Personal emergency response system. Home communicator Model 7000L may not sense the phone line under certain unusual landline phone c... Class II Lifeline Systems, Incorporated
Apr 22, 2015 C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.
Apr 22, 2015 Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for gener... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were reca... Class II Windstone Medical Packaging, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.