FDA Device Recalls
Search FDA medical-device recalls by manufacturer or product code. Recalling firm, classification, root cause, and FDA determination — the medical-device half of the healthcare-recall picture.
Why this exists
Device-recall classifications are FDA's severity scale: Class I means a reasonable probability of serious adverse health consequences or death. For an MSP serving a hospital network, a healthcare-vertical PE thesis, or a med-device acquirer, the recent recall record tells you about the quality system in a way a website never will.
Frequently asked questions
What's the difference from FDA Drug Recalls?
Same shape, medical devices instead of drugs. Returns recalling firm, product code, classification, root cause analysis, FDA determination, and distribution. Sourced from openFDA's medical-device enforcement endpoint.
What's a 510(k) and how does it relate?
510(k) is the FDA's premarket-notification pathway for medical devices substantially equivalent to a marketed predicate device. Recalls often surface 510(k)-cleared devices where post-market surveillance found unexpected failures. The recall record cross-references to the original 510(k) when available.
Healthcare-diligence use case?
Medical-device M&A target-company recall history, hospital purchasing risk assessment, FDA inspection-history flagging (recalls correlate with inspection observations), and journalism on device-safety patterns.