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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Apr 4, 2025 Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... Potential for internal fastening mechanism within generator of mobile x-Ray to fail. Class II Micro-X Ltd.
Apr 4, 2025 Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MX... Potential for internal fastening mechanism within generator of mobile x-Ray to fail. Class II Micro-X Ltd.
Mar 28, 2025 Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load... Class II Micro-X Ltd.
Mar 28, 2025 Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load... Class II Micro-X Ltd.
Oct 23, 2024 MICRO-X Rover Mobile X-ray System, # MXU-RV19 During internal testing it was found that if the system is Ready to expose and the hand switch is... Class II Micro-X Ltd.
Oct 22, 2024 MICRO-X Rover Mobile X-ray System, # MXU-RV35 Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 t... Class II Micro-X Ltd.
Nov 28, 2023 MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray Sy... Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the o... Class II Micro-X Ltd.
May 31, 2023 MICRO-X Rover Mobile X-ray System, # MXU-RV35 Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough... Class II Micro-X Ltd.
Aug 31, 2022 MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 Software calibration error with product equip with a Dose Area Product (DAP) meter. This results... Class II Micro-X Ltd.

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.