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 / terms
Coverage
39,000 enforcement actions
API endpoint

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/. 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. AI Analytics-authored metadata and normalization are CC0 only where expressly stated.

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