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 |
|---|---|---|---|---|
| Mar 26, 2019 | EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x1... | Intermittent heat seal failures on the outer pouch of some EZ Derm products. | Class II | Molnlycke Health Care, Inc |
| Jul 26, 2017 | 7x10" Small Utility Positioner with Cover | Products may not meet specifications due to possible presence of metal shavings. | Class II | Molnlycke Health Care, Inc |
| Jul 26, 2017 | 9x15" Medium Utility Positioner with Cover | Products may not meet specifications due to possible presence of metal shavings. | Class II | Molnlycke Health Care, Inc |
| Apr 24, 2017 | Brennen Skin Graft Mesher. Surgical instrument designed to expand skin gra... | Sterilization validation failure. | Class II | Molnlycke Health Care, 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.