The FDA recall database lists medical device recalls the FDA has classified since 2002. This guide covers how to search it and openFDA's recall data, what each recall class means, why posting dates mislead, and how ClinicaLister puts recalls next to a device's clearance and trials.
A device recall is a correction or removal of a device that violates FDA law — usually started by the manufacturer. The FDA reviews it and assigns a class by health hazard. Class I: a reasonable probability that use of the product will cause serious adverse health consequences or death. Class II: use may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: use is not likely to cause adverse health consequences.
The FDA's recall database covers recalls classified since November 2002. Since January 2017 it may also include correction or removal actions a firm started before FDA review. Each record names the product, product code, recalling firm, reason for recall, root cause, quantity and distribution, and the 510(k) or PMA number where known.
openFDA publishes two related datasets: device recalls, and recall enforcement reports — the weekly enforcement report entries with recall number, classification, status and distribution pattern.
Search the FDA database for specific recalls, and openFDA when you need counts or a list across many products.
On the FDA recall database, search by product name, recalling firm or product code — the product code returns every recall in a device category.
Choose Class 1, 2, 3 or not yet classified, and set a recall date range. You can also filter by reason for recall, root cause, recall number or PMA/510(k) number.
The date a recall is posted is when the FDA classified it, not necessarily when it began; firms often contact customers well before classification. Check the initiation date in the record.
Query api.fda.gov/device/enforcement.json or /device/recall.json — for example search=product_code:DXY with count=classification.exact for recalls by class. Each call returns up to 1,000 records; a free API key raises the daily limit from 1,000 to 120,000 requests.
Where a recall can be matched to a device — by product code and recalling firm — it appears in that device's view next to its 510(k) or PMA, adverse event reports and linked clinical trials.
Recall history by class over time shows whether a device category is getting safer or noisier, without building openFDA queries.
Recall changes for devices linked to the trials you follow show up in the in-app Monitoring view.
Through the ClinicaLister MCP server, an AI assistant can list the recalls held for a device or company.
39,800+
openFDA device recall enforcement records
Weekly
sync from openFDA
Class I–III
classification on every classified record
Counts measured on the ClinicaLister platform database, September 2026. ClinicaLister holds openFDA's device recall enforcement records, not the separate openFDA device recall dataset. Few records carry a device identifier, so recalls are matched to devices by product code and firm where possible, and many remain unmatched.
Class I is the most serious: a reasonable probability of serious adverse health consequences or death. Class II covers temporary or medically reversible harm, or a remote chance of serious harm. Class III products are not likely to cause adverse health consequences.
It covers device recalls the FDA has classified since November 2002.
The database's posting date is when the FDA classified the recall. Manufacturers often notify customers earlier, so check the recall initiation date in the record.
Yes. openFDA publishes /device/recall.json and /device/enforcement.json. ClinicaLister does not offer an API; programmatic access is through its MCP server for AI assistants.
See recalls next to the devices and trials you track
Built for the Regulatory Affairs Specialist. See it in the product: Drug & Device Details. All data sources