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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

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DateProductReasonClassFirm
May 12, 2023 TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928 Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... Class II Full Vision Inc
May 12, 2023 TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927 Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... Class II Full Vision Inc
May 12, 2023 TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... Class II Full Vision Inc
May 12, 2023 TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... Class II Full Vision Inc
May 12, 2023 TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926 Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... Class II Full Vision Inc
May 12, 2023 TRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929 Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... Class II Full Vision Inc
May 12, 2023 TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate... Class II Full Vision Inc
Aug 31, 2022 FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926 This has been identified a rare occurrence, under a specific scenario, where the circuit is found... Class II Full Vision Inc
Aug 31, 2022 FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 110V, Model #317-07928 This has been identified a rare occurrence, under a specific scenario, where the circuit is found... Class II Full Vision Inc
Aug 31, 2022 FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE This has been identified a rare occurrence, under a specific scenario, where the circuit is found... Class II Full Vision Inc
Aug 31, 2022 FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE... This has been identified a rare occurrence, under a specific scenario, where the circuit is found... Class II Full Vision Inc
Aug 31, 2022 FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE This has been identified a rare occurrence, under a specific scenario, where the circuit is found... Class II Full Vision Inc
Aug 31, 2022 FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927 This has been identified a rare occurrence, under a specific scenario, where the circuit is found... Class II Full Vision Inc
Aug 31, 2022 FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929 This has been identified a rare occurrence, under a specific scenario, where the circuit is found... Class II Full Vision 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.