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 |
|---|---|---|---|---|
| May 20, 2022 | CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enume... | High number of total images/unassigned events including (dual positives) and the potential for fa... | Class II | Menarini Silicon Biosystems |
| Apr 4, 2018 | CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLS... | Unusually high number of total images/unassigned events may require additional time and effort fo... | Class II | Menarini Silicon Biosystems |
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.