Browse Device Recalls

256 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 256 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 256 FDA device recalls.

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DateProductReasonClassFirm
Dec 21, 2012 MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integ... Integra determined there is a possibility that the Base Units may break during use. Class II Integra LifeSciences Corp.
Dec 10, 2012 Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning... Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occu... Class II Integra LifeSciences Corp.
Jun 7, 2012 Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley Cit... Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadve... Class III Integra LifeSciences Corp. d.b.a. Integra Pain ...
Feb 9, 2012 Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive... Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during su... Class II Integra LifeSciences Corp.
Oct 11, 2011 Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is... The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l f... Class II Integra LifeSciences Corp.
Oct 11, 2011 Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft ... The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for... Class II Integra LifeSciences Corp.

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.