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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Dec 4, 2025 Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (C... AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. Class II Mobius Imaging, LLC
Dec 4, 2025 Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (C... AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. Class II Mobius Imaging, LLC
Dec 7, 2022 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... Stryker received one report of an injury to an untrained user that occurred while the untrained u... Class II Mobius Imaging, LLC
Nov 18, 2022 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to ... Class II Mobius Imaging, LLC
Aug 1, 2018 AIRO Mobile CT System Model # MobiCT-32 The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with softwar... Class II Mobius Imaging, LLC
Sep 26, 2017 AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ i... If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is ... Class II Mobius Imaging, LLC
Dec 8, 2014 Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomograph... There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Im... Class II Mobius Imaging, 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.