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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 22, 2020 The EOSedge system may acquire two simultaneous orthogonal planar images for ... Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been... Class II EOS Imaging
Aug 1, 2018 sterEOS workstation 3D projections may be incorrect when the pair of images used is a secondary capture generated fr... Class II EOS Imaging
May 30, 2017 ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle... ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not ... Class II EOS Imaging
Feb 17, 2015 EOS, Digital radiography system used in general radiographic examinations. When performing calibration, an alert message on the spectral filtration of the X-ray beam may be... Class II Eos Imaging Inc
Nov 29, 2013 steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in process... Error copying information to the clinical file and to the report when two 3D models are opened si... Class II EOS Imaging
Nov 7, 2013 EOS System X- ray beam Digital radiography system used in general radiogra... EOS imaging discovered during production internal testing that the X-ray beam collimation set up ... Class II EOS Imaging
Jun 19, 2012 EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography ... It was discovered of several generator failures of the EOS System due to failure of its anode con... Class II Eos Imaging 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.