Dataset family
FDA Enforcement Reports
FDA Recall Enforcement Reports — the agency's record of every drug and medical-device recall, with the recall classification (Class I, II, or III), the recalling firm, the reason for recall, the distribution pattern, and whether the action was voluntary or FDA-mandated. Published through openFDA. 56,777 recalls. Snapshot 2026-06-14.
Dataset spec
| dataset_id | fda-enforcement-reports |
|---|---|
| snapshot_date | 2026-06-14 |
| sha256 | Computed per snapshot — see /trust/integrity |
| doi | 10.5072/fonteum.dataset.fda-enforcement-reports (reserved) |
| update_cadence | Weekly (openFDA refresh) |
| license | US Government Works (public domain, 17 U.S.C. §105) |
Studies citing FDA Enforcement Reports (1)
- How serious is the average FDA recall? About one in eleven is the most serious tier2026-06-14 · 11 min
Sample row
{
"product_kind": "device",
"recall_number": "Z-1234-2026",
"classification": "Class I",
"recalling_firm": "Example Medical Inc.",
"reason_for_recall": "Device may fail to deliver therapy",
"voluntary_mandated": "Voluntary: Firm initiated",
"recall_initiation_date": "2026-03-04"
}