Browse Device Recalls
4 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4 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 4 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 13, 2014 | VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011... | Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an... | Class II | Accumetrics Inc |
| Nov 14, 2013 | VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690... | Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information... | Class II | Accumetrics Inc |
| Feb 6, 2012 | VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay... | The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; sp... | Class II | Accumetrics Inc |
| Feb 6, 2012 | VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage... | The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; sp... | Class II | Accumetrics Inc |
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.