Browse Device Recalls
9 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 9 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 9 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 28, 2019 | ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) an... | Some of the electrodes may have been assembled incorrectly, preventing delivery of defibrillation... | Class II | Bio-Detek, Inc. |
| Sep 16, 2014 | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8... | Product sterility is not assured | Class II | Bio-Detek, Inc. |
| Sep 16, 2014 | ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012... | Product sterility is not assured | Class II | Bio-Detek, Inc. |
| Sep 16, 2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwi... | Product sterility is not assured | Class II | Bio-Detek, Inc. |
| Sep 16, 2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwi... | Product sterility is not assured | Class II | Bio-Detek, Inc. |
| Aug 26, 2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part num... | Sterility of device is not assured | Class II | Bio-Detek, Inc. |
| Aug 26, 2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012... | Sterility of device is not assured | Class II | Bio-Detek, Inc. |
| Aug 26, 2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadw... | Sterility of device is not assured | Class II | Bio-Detek, Inc. |
| Mar 12, 2013 | Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepa... | Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector w... | Class II | Bio-Detek, 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.