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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.

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DateProductReasonClassFirm
Aug 18, 2021 CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Produc... Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site. Class II In2bones USA, LLC
Nov 14, 2018 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Nu... The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. T... Class II In2bones USA, LLC
Jul 16, 2018 CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones ... CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, righ... Class II In2bones USA, LLC
Jul 16, 2018 CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones ... CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, righ... Class II In2bones USA, LLC

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.