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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
May 3, 2019 OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERIL... The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (... Class II XTANT MEDICAL INC
Dec 19, 2018 Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034... This recall has been initiated due to a change in packaging and sterilization method to address p... Class II XTANT MEDICAL INC
Apr 12, 2017 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The produc... The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cob... Class II XTANT MEDICAL 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.