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Abbott Diabetes Care, Inc. FDA Recalls

10 recalls on file across devices, 8 of them Class I and 9 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a componentClass INov 24, 2025Due to a manufacturing process issue that may cause carbon b	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect	Class IDevices	Nov 24, 2025
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a componentClass INov 24, 2025Due to a manufacturing process issue that may cause carbon b	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect	Class IDevices	Nov 24, 2025
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a componentClass INov 24, 2025Due to a manufacturing process issue that may cause carbon b	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect	Class IDevices	Nov 24, 2025
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FrClass INov 24, 2025Due to a manufacturing process issue that may cause carbon b	Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect	Class IDevices	Nov 24, 2025
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring SystemClass IJul 24, 2024Users of the FreeStyle Libre 3 sensors reported situations w	Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose	Class IDevices	Jul 24, 2024
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 SystemClass IIJul 12, 2023If blood glucose monitoring system users attempt to start a	If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for th	Class IIDevices	Jul 12, 2023
FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring SyClass IFeb 13, 2023Lithium-ion batteries in glucose monitoring system readers m	Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use	Class IDevices	Feb 13, 2023
FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring Class IFeb 13, 2023Lithium-ion batteries in glucose monitoring system readers m	Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use	Class IDevices	Feb 13, 2023
FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose MonitoClass IFeb 13, 2023Lithium-ion batteries in glucose monitoring system readers m	Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use	Class IDevices	Feb 13, 2023
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating SystemClass IIFeb 9, 2023If using affected glucose monitoring app on Android 13 Opera	If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may b	Class IIDevices	Feb 9, 2023

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