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Browse Device Recalls

18 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 18 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 18 FDA device recalls.

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DateProductReasonClassFirm
Nov 24, 2025 FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The F... Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... Class I Abbott Diabetes Care, Inc.
Nov 24, 2025 FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The F... Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... Class I Abbott Diabetes Care, Inc.
Nov 24, 2025 FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The F... Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... Class I Abbott Diabetes Care, Inc.
Nov 24, 2025 FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeSt... Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... Class I Abbott Diabetes Care, Inc.
Jul 24, 2024 FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 ... Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously ... Class I Abbott Diabetes Care, Inc.
Jul 12, 2023 FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Li... If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn'... Class II Abbott Diabetes Care, Inc.
Feb 13, 2023 FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the ... Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza... Class I Abbott Diabetes Care, Inc.
Feb 13, 2023 FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the ... Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza... Class I Abbott Diabetes Care, Inc.
Feb 13, 2023 FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the ... Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire haza... Class I Abbott Diabetes Care, Inc.
Feb 9, 2023 FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when use... If using affected glucose monitoring app on Android 13 Operating System, extended periods of sign... Class II Abbott Diabetes Care, Inc.
Nov 14, 2019 FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 000938... Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke... Class II Abbott Diabetes Care, Inc.
Nov 14, 2019 Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653 Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke... Class II Abbott Diabetes Care, Inc.
Nov 14, 2019 Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023,... Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke... Class II Abbott Diabetes Care, Inc.
Feb 19, 2014 FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Dis... Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... Class I Abbott Diabetes Care, Inc.
Feb 19, 2014 FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. S... Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... Class I Abbott Diabetes Care, Inc.
Nov 18, 2013 FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. ... Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low bl... Class I Abbott Diabetes Care, Inc.
Nov 18, 2013 FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 co... Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low bl... Class I Abbott Diabetes Care, Inc.
Apr 15, 2013 FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic ... AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Gluco... Class I Abbott 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.