Browse Device Recalls
2 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 15, 2025 | Estrone RIA, REF: DSL8700 | The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause ... | Class II | Immunotech A.S. |
| Jun 12, 2025 | Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA i... | Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary inj... | Class II | Immunotech A.S. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.