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 |
|---|---|---|---|---|
| Apr 30, 2013 | TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 T... | American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable han... | Class II | American Optisurgical Inc |
| Apr 30, 2013 | FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. | American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in re... | Class II | American Optisurgical Inc |
| Mar 30, 2013 | American Optisurgical's TX1 Tissue Removal System Console. The console is a s... | The recall has been initiated due to an overheating protection voltage suppressor on the redundan... | Class II | American Optisurgical Inc |
| Feb 22, 2012 | TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is a... | Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading t... | Class II | American Optisurgical 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.