FDA Device Enforcement Actions (Class I/II/III recalls)

Dataset · US Food and Drug Administration · source URL ↗

Classified device enforcement actions — 39k recalls with recall_number PK. Each carries classification (Class I life-threatening / II reversible / III unlikely harm), status (Ongoing / Completed / Terminated), product type, voluntary vs mandated, distribution pattern, initiating firm + address, dates. Joins to fda_device_recalls via product line.

Source organization
US Food and Drug Administration
License / terms
Coverage
39,000 enforcement actions
Latest local indexed-row date
2026-05-18
API endpoint

Keywords

FDA device enforcementClass I recallClass II recallClass III recallmedical device safetydevice classification

Provenance

The listed URL identifies a referenced source; it does not by itself document the ingestion endpoint. Referenced source URL: https://open.fda.gov/apis/device/enforcement/. Source-specific terms apply. US federal employee-authored works are generally public domain under 17 USC 105; non-federal and third-party material retains source terms. Free or keyless access does not alter source terms. Metadata and normalization authored by MORVS (AI Analytics LLC) are CC0 only where expressly stated.

For agents