FDA
FDA Device Establishment Registration →FDA device establishment registration and listing — registration number, firm name, establishment type, and location.
FDADrug and device safetyObserved 2026-06-14
FDA Enforcement Reports
Drug and device recall enforcement reports — recalling firm, classification, reason, and status from the openFDA enforcement feeds. Source:
Illustrative FHIR Organization mapping
How one record can be normalized.
{
"resourceType": "Organization",
"id": "fda-firm-example",
"_source": "fda-enforcement-reports",
"_methodology": "fda-enforcement/v1",
"name": "Example Manufacturer Inc.",
"extension": [{ "url": "recallClassification", "valueString": "Class II" }]
}This example documents a normalized shape; it does not establish that a FHIR endpoint or bulk export is available for this catalog entry. When a record includes _source, _methodology, snapshot-date, or confidence fields, those fields are nullable and delivery surfaces can return different subsets. Published bulk files are listed separately in the bulk manifest.
Fields in this record
What each field in the illustrative Organization mapping means.
The fields below are derived from the displayed illustrative FHIR Organization mapping. When a record includes source-metadata fields (_source, _methodology, and a snapshot date), they describe that delivered record. Those fields are nullable and may be absent from a response; identity fields key the record and data fields carry the measured values.
| Field | Type | Role |
|---|---|---|
resourceType | string | Identity |
id | string | Identity |
_source | string | Provenance |
_methodology | string | Provenance |
name | string | Data |
extension | array | Data |
Dataset facts
| Field | Value |
|---|---|
| Agency | |
| Category | Drug and device safety |
| Records | |
| Temporal coverage | 2004–2026 |
| Publisher cadence (nominal) | Weekly |
| Load timing | No load-time guarantee; date shown is the catalog observation for this row count. |
| Catalog observation date | 2026-06-14 |
| Illustrative FHIR mapping | Organization |
| Methodology | fda-enforcement/v1 |
| Measured | Recall number, classification, recalling firm, reason for recall, and status per enforcement report |
| Upstream source | api.fda.gov → |
Get access
How to reach this dataset.
Dataset-specific delivery formats are confirmed during pilot review. This catalog entry does not promise a bulk file or FHIR endpoint. Pilot requests are reviewed within one business day; there is no charge during the pilot period.