Browse Device Recalls
1,708 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,708 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 1,708 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Apr 20, 2015 | Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Eye Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Neurosurgery Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Bariatric Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Set Up Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Gyn Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Dev... | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Stradi 4500 - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Face Lift Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | ACL Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used dur... | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Basic Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Breast Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during s... | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Tummy Tuck Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | DND Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Advanced Vein Care - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Open Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Upper Extremity Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Cysto Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Face Neck Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Podiatry Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Face Lift Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pac... | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Hand Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during s... | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | ENT Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Hand Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Vein & Vascular Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Standard Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon L... | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Custom Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Pediatric Pack - contains Devon Light Glove Used during surgery | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used d... | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
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.