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Browse Device Recalls

315 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 315 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 315 FDA device recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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.
Apr 22, 2015 Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(... 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 D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience cus... 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.