FDA Center for Devices Recall Events (CDRH cfres registry)

Dataset · US Food and Drug Administration · primary source ↗

Every CDRH device recall event — 58k records with cfres_id PK. Each carries root cause, corrective action, recalling firm + FEI, distribution pattern, product quantity, status (Open/Pending/Terminated), 510(k) joins, posted/initiated/terminated dates. Deeper than the enforcement table: includes pre-classification recalls and full root-cause narrative.

Source agency
US Food and Drug Administration
License / terms
Coverage
58,000 device recall events
API endpoint

Keywords

FDA device recallCDRH recalldevice safetymedical device defectcorrective actionroot causeFDA cfres

Provenance

Every record in this dataset can be traced back to its primary source at https://open.fda.gov/apis/device/recall/. 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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