Browse Device Recalls
52 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 52 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 52 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 18, 2013 | St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery Sy... | The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when... | Class I | St Jude Medical Inc |
| Mar 28, 2012 | Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, S... | St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which w... | Class III | St Jude Medical 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.