Browse Device Recalls
309 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 309 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 309 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 8, 2013 | FastPack Testosterone Immunoassay Chemilunescence assay for the determinati... | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... | Class II | Qualigen Inc |
| Nov 8, 2013 | FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescen... | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... | Class II | Qualigen Inc |
| Sep 16, 2013 | PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lowe... | PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding ... | Class I | Pentax Medical Company |
| Jul 31, 2013 | Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic image... | A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which include... | Class II | Fujinon Inc |
| Nov 5, 2012 | SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane... | A manufacturing defect was observed for the membrane changer insert that does not allow electroly... | Class II | Sentec AG |
| Nov 5, 2012 | SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign ... | A manufacturing defect was observed for the membrane changer insert that does not allow electroly... | Class II | Sentec AG |
| Oct 25, 2012 | INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen... | A manufacturing defect has been identified which could results in the small tube becoming dislodg... | Class II | Carl Zeiss Meditec, Inc. |
| Oct 25, 2012 | INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen... | A manufacturing defect has been identified which could results in the small tube becoming dislodg... | Class II | Carl Zeiss Meditec, Inc. |
| Oct 25, 2012 | INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen... | A manufacturing defect has been identified which could results in the small tube becoming dislodg... | Class II | Carl Zeiss Meditec, 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.