FreeStyle Libre 2 Continuous Glucose Monitoring System
Abbott Diabetes Care Inc. · Continuous glucose monitors
Active recall recordLatest source check Oct 27, 2026
Loading MedWatcher information…
Devices and FDA recall records listed on MedWatcher for Abbott Diabetes Care Inc..
This page covers the devices and recall records listed below, not the complete product catalogue or recall history. A recall may apply only to specific models, lots, or serial numbers.
Device and manufacturer names are linked using official product, UDI, or FDA records. The source links below show the supporting information.
Official records may use a legal name, brand, division, or shortened name. Similar names do not necessarily refer to the same manufacturer.
Abbott Diabetes Care Inc. · Continuous glucose monitors
Active recall recordLatest source check Oct 27, 2026
Abbott Diabetes Care Inc. · Continuous glucose monitors
Active recall recordLatest source check Oct 27, 2026
Abbott Diabetes Care Inc. · Continuous glucose monitors
No linked recall recordsLatest source check Oct 27, 2026
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose…
If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high…
If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2…