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 |
|---|---|---|---|---|
| Dec 14, 2015 | BD Viper LT software, version 3.00H | BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper ... | Class II | Bd Diagnostic |
| Dec 9, 2013 | BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit ins... | Improperly functioning component of a diagnostic medical device may cause false negative results ... | Class II | Becton Dickinson & Co. |
| Dec 9, 2013 | BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnos... | Improperly functioning component of a diagnostic medical device may cause false negative results ... | Class II | Becton Dickinson & Co. |
| May 22, 2012 | BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part**... | Leakage in Cepheid SmartCycler reaction tubes. | Class II | Becton Dickinson & Co. |
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.