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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
Jan 3, 2025 Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer... Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorr... Class II XTANT Medical Holdings, Inc
Aug 21, 2024 Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-... Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not h... Class II XTANT Medical Holdings, Inc
Nov 28, 2023 Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws lab... Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorr... Class II XTANT Medical Holdings, 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.