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Browse Device Recalls

54 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 54 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 54 FDA device recalls.

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DateProductReasonClassFirm
Feb 6, 2023 Phoenix mKDR Xpress, digital mobile diagnostic x-ray system Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. Class II SEDECAL SA
Aug 12, 2022 Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mob... Due to un-commanded movement of mobile x-ray unit. Class II SEDECAL SA
Oct 14, 2021 MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 While cleaning or disinfecting the system, if the process is not followed as described in the man... Class II SEDECAL SA
Mar 23, 2015 Sedecal SA Mobile Diagnost w DR x-ray system Due to a software defect, the system may sporadically apply the default x ray exposure parameters... Class II Sedecal USA, 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.