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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Jan 30, 2026 Tandem pumps are battery-operated infusion pumps capable of both basal and bo... The Czech language user guide contained multiple translation errors. The most significant error ... Class II Tandem Diabetes Care, Inc.
Oct 6, 2025 Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are batt... Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or ma... Class I Tandem Diabetes Care, Inc.
Aug 5, 2025 t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology,... A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and ve... Class II Tandem Diabetes Care, Inc.
Jul 21, 2025 Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF:... Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16")... Class I Tandem Diabetes Care, Inc.
Jul 3, 2025 t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobi... an app defect that occurs when the phone is set to a right-to-left language, which causes app-pu... Class II Tandem Diabetes Care, Inc.
Feb 27, 2025 Tandem Mobi Insulin Pump with Interoperable Technology A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,... Class I Tandem Diabetes Care, Inc.
Feb 27, 2025 t:slim X2 Insulin Pump with Interoperable Technology A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,... Class I Tandem Diabetes Care, Inc.
Mar 5, 2024 t:connect mobile app used in conjunction with t:slim X2 insulin pump with Co... During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iO... 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.