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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
May 24, 2022 t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insu... Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate ... Class II Tandem Diabetes Care Inc
May 24, 2022 t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insu... Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate ... Class II Tandem Diabetes Care Inc
Sep 10, 2020 t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump ... Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump bat... Class II Tandem Diabetes Care Inc
Apr 23, 2018 t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4... The fuel gauge, the component that reads and reports the battery parameters to the pump, could pr... Class II Tandem Diabetes Care Inc
Jan 10, 2014 T:slim Insulin Delivery System Insulin Infusion Pump Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for... Class I Tandem Diabetes Care 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.