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

Dataset · US Food and Drug Administration · primary source ↗

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 agency
US Food and Drug Administration
License
CC0 / US public domain
Coverage
39,000 enforcement actions
API endpoint
/api/v1/fda/device-enforcement/recent

Keywords

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

Provenance

Every record in this dataset can be traced back to its primary source at https://open.fda.gov/apis/device/enforcement/. Underlying content is a US federal government work (public domain under 17 USC §105); our derived data is licensed CC0 1.0.

For agents