Browse Device Recalls
164 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 164 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 164 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 20, 2015 | Glaucoma 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 | General 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 | Suction 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 | Blepharoplasty 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 | Head & 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 | Surgical Pack and General Surgery Pack - contains Devon Light Glove Used du... | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Skin and Vein 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 | Vasc Custom Kit - 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 | Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glo... | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Shoulder 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 | Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during sur... | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component ... | Class II | Stradis Healthcare, LLC. |
| Apr 20, 2015 | Arthroscopy 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 | Mississippi 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 | Lima 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. |
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.