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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
Feb 3, 2026 Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (... There is a potential issue that can lead to discordance between the simulated needle trajectory/t... Class II GE Medical Systems, LLC
Feb 11, 2021 Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Ref... Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of th... Class II Imactis
Aug 24, 2020 Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component ... The firm has received reports concerning the patient fiducial disk separating from the body and u... Class II Imactis
Aug 1, 2019 Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 ... The firm has become aware that the sensor cover, a component of the single-use navigation kit ma... Class II Imactis

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.