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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
May 23, 2018 Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing... This email is to provide notification that, due to a software bug that has been corrected, the Ra... Class II Ortho Kinematics, Inc
Mar 2, 2017 Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA so... Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VM... Class II Ortho Kinematics, Inc
Jan 11, 2017 Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quanti... Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read ... Class II Ortho Kinematics, Inc
Aug 12, 2016 Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. ... Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug... Class II Ortho Kinematics, 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.