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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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 regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing... 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: 800415, Sterile, OR0484 - Shoulder System Pk - 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 Minor Lithotomy Pack, Kit number 002650-7 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 regard Item Number: 800558, Sterile, OR0647 - Extremity - 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: 880326, Sterile, GS0757 - Major Basin - surgical kit con... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used fo... 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 Vanguard M Unicondylar Tibial Trial For use during knee joint replacement. The Left and Right orientation of the trial was incorrectly etched on one side. When the instrum... Class II Biomet, Inc.
Apr 22, 2015 D&C/GYN/Hysteroscopy Pack, Kit number PSS3341 convenience custom kits used f... 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: 800091, Sterile, LD0692 - 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 GYN Lap Pack, Kit number PSS2194(B 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 Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS38... 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 Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, 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 Peri Kit, Kit number PSS1037 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 Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits u... 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 OB/GYN Pack, Kit number AMS2038 convenience custom kits used for general s... 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 Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(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 regard Item Number: 800617, Sterile, NU0768 - 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 ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. 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 Ortho Minor Pack, Kit number AMS3710 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 Port Access Kit, Kit number PSS1505(C 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 C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience cust... 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: 800401, Sterile, GS0470 - Lap Pk - surgical kit containi... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience ... 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: 880328, Sterile, HT0759 - Pacemaker 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 Total Joint Pack, Kit number 006358-5 and 006358-6 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 regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit con... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, ... 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 Eye Tray, Kit number PSS1834 and PSS1939 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 regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - 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 800565001, Sterile, CV0654A - Pediatric Heart - 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: 800413001, Sterile, CV0482A - Vascular 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 Dr Mullins Kit, kit number PSS1861(A 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 Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. conveni... 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 Pack, Kit number AMS3326 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 Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom ki... 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: 800554002, Sterile, GS0643B - Pediatric Basic - 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 Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits u... 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: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit c... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for ge... 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 Pack, Kit Number PSS3516 and PSS3516(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 Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits us... 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 Tray, Kit number AMS1200(B and AMS1200(C 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 regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - 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 regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - 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 regard Item Number: 800091001, Sterile, LD0692A - 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 regard Item Number: 800551, Sterile, GS0640 - Lap Chole - 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 Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used f... 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 GLBSC Minor Pack, Kit number PSS2644 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 Lipo Pack, Kit number AMS4420 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 GYN Pack, Kit number PSS2643 convenience custom kits used for general surger... 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.