FDA medical device recalls database
All 58,607 FDA device recalls and 39,365 enforcement reports — searchable by product, recalling firm, or product code, with Class I–III classifications and recall reasons.
Recalls vs. enforcement reports
The FDA publishes two related datasets. The recalls database lists each recalled product with the recalling firm, the reason, distribution, and status. The enforcement reports add the FDA's hazard classification: Class I (reasonable probability of serious harm or death), Class II (temporary or reversible harm), and Class III (unlikely to cause harm). BEUDAMED indexes both and links them by recall event, so you see the classification next to the recall.
Who needs this: procurement and distributors verifying suppliers, RA/QA teams doing post-market surveillance on their own and similar devices, and anyone writing the recall section of a PSUR.
From lookup to analysis
Check a firm or product
Search by recalling firm or product description to verify a supplier or check a specific device's recall history.
Search the recalls database →Trend a device category
All recalls for a product code over your reporting period — alongside adverse event trends and enforcement classes, formatted for a PSUR.
Generate a PSUR report →