United States Medical Device Recalls
Medical devices pulled from the US market, with the reason, risk class and recalling company.
FDA enforcement records for recalled medical devices, covering the product description, the reason for the recall, the risk classification, the recalling firm and the distribution pattern. It shows which devices in circulation have been found defective or dangerous. Hospitals, device distributors, insurers and safety monitoring tools use it to check exposure and trigger alerts.
Source: openFDA — Device Enforcement Reports · Public domain (U.S. Government Work) · Source: openFDA, U.S. Food and Drug Administration. Not endorsed by the FDA.
Endpoints
Every request is authenticated with your X-API-Key and counted against your plan.
- GET /v1/data/united-states-medical-device-recalls
- GET /v1/data/united-states-medical-device-recalls/search?q=...
- GET /v1/data/united-states-medical-device-recalls/{key}
Base path /v1/data/united-states-medical-device-recalls · full reference in the interactive docs. Also exposed as an MCP tool for AI agents.
Fields
| Field | Type | Description |
|---|---|---|
| recall_number | str | FDA identifier for the recall event |
| event_id | str | Identifier grouping related recall records |
| status | str | Whether the recall is ongoing, completed or terminated |
| classification | str | Risk class of the recall, Class I being most serious |
| product_description | str | Description of the recalled device |
| reason_for_recall | str | Why the device was recalled |
| recalling_firm | str | Company conducting the recall |
| firm_city | str | City of the recalling company |
| firm_state | str | State of the recalling company |
| firm_country | str | Country of the recalling company |
| voluntary_or_mandated | str | Whether the recall was voluntary or FDA mandated |
| distribution_pattern | str | Where the affected devices were distributed |
| product_quantity | str | Quantity of product affected |
| recall_initiation_date | date | Date the firm began the recall |
| report_date | date | Date the recall was published by the FDA |
| termination_date | date | Date the recall was terminated, if closed |
What you get
FAQ
- What does Class I mean?
- Class I is the FDA's most serious category, used where there is a reasonable probability that the product will cause serious health consequences or death.
- Does it cover devices sold outside the US?
- It covers recalls reported to the FDA, but many of those products are distributed internationally and the distribution pattern field usually says where.
- Is patient information included?
- No. Records describe products and companies only.
Pricing
Simple, transparent pricing
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- Usage dashboard
Enterprise
Unlimited access for high-volume use
- Unlimited API requests
- All endpoints included
- Priority support
- Usage dashboard
- Dedicated support channel
Getting Started
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