Source data
The register is built directly from the openFDA Device Enforcement Reports API, the FDA's canonical public feed of medical-device recalls and field corrections. Each recall is published with the FDA's own classification (Class I, II, or III), the recalling manufacturer, the distribution scope, the reason for recall, the affected lot or serial range, and a lifecycle status (Ongoing, Pending, Completed, Terminated).
Where available, the openFDA enrichment overlay includes the 510(k) clearance number(s), the PMA approval number(s), and the medical-specialty classification associated with the device. These are surfaced on the per-recall pages alongside the recall record.
FDA device recall classifications
- Class I — reasonable probability that use of, or exposure to, the device will cause serious adverse health consequences or death. The highest-impact class
- Class II — use of the device may cause temporary or medically reversible adverse health consequences; remote probability of serious adverse health consequences
- Class III — device violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences
What's published here
The openFDA Device Enforcement endpoint exposes the most recent 25000 records via paginated access. The index page displays the top 3000 most-actionable recalls (Class I, Ongoing, recent first); the full set is available via the CSV exports.
Per-recall detail pages are published for every Class I device recall and every currently-Ongoing recall (whatever the class). For lower-class terminated recalls, the row is searchable on the index and the full record is in the CSV; we do not generate a dedicated page in the MVP.
The operational response language on Ongoing-recall pages is templated by class. For implanted devices, recalls typically require patient-level notification per the recalling firm’s protocol; the free register surfaces the recall but the patient-notification workflow is the hospital's or implanting physician's responsibility.
What's not here yet
- MAUDE adverse-event ingest — FDA's Manufacturer and User Facility Device Experience database tracks pre-recall adverse-event reports. The disproportionality-analysis signal-detection layer that surfaces failing devices before recall is planned as the paid Forensic
- Surgeon-level revision-rate signal — CMS Medicare claims expose revision rates per surgeon and per facility, a leading indicator that often precedes a recall by years (Essure, transvaginal mesh, metal-on-metal hip were all visible in this signal). Planned as the paid layer
- Class-action filing cross-reference — PACER class certifications and complaints, indexed by device manufacturer and model. The plaintiff-firm sales surface
Limits
openFDA is FDA-provided but carries a disclaimer that the data should not be the sole basis for clinical or operational decisions. The openFDA pagination cap (skip=25,000) limits a single ingest pass to the most recent 25,000 records; Branmoor re-ingests on each site deploy. For each individual recall, the canonical record is the FDA's enforcement report at FDA Recalls. The recall_number and lot information presented here are sourced verbatim from openFDA.