Abbott Diabetes Care Inc.

MedWatcher tracks the reviewed device families FreeStyle Libre 2 Continuous Glucose Monitoring System, FreeStyle Libre 3 Continuous Glucose Monitoring System under the canonical manufacturer identity Abbott Diabetes Care Inc.. The recall records on this page are limited to 5 owner-approved FDA recall actions.

What MedWatcher tracks

This page covers only the reviewed device families and FDA recall actions shown below. It is not a complete product catalogue, and a recall does not necessarily affect every unit or configuration in a device family.

Reviewed device families: 2
Matched recall actions: 4
Source records last checked: Oct 8, 2026

Manufacturer identity and source matching

The manufacturer and device-family relationships come from the reviewed canonical-device inventory. Recall coverage is limited to the exact candidate IDs approved and published in the FUS-265 cohort; complete regulator payloads remain in the private source ledger.

Source databases can use a legal name, brand, division, or shortened name. MedWatcher retains the form used as evidence rather than treating every similar name as the same manufacturer.

Abbott Diabetes Care, Inc.Source-name variantOwner-approved openFDA recall-match cohort (FUS-265)Evidence source (opens in a new tab)
Telcare, LLCSource-name variantOwner-approved openFDA recall-match cohort (FUS-265)Evidence source (opens in a new tab)

Sources used for this page

U.S. Food and Drug AdministrationFDA medical device recall recordsLast checked Aug 16, 2026 openFDAMedical device recall bulk dataLast checked Aug 16, 2026

Page reviewed Aug 17, 2026 by fusiondesigner@gmail.com · Next review by Nov 17, 2026.

Continuous glucose monitors

View category

FreeStyle Libre 2 Continuous Glucose Monitoring System

Abbott Diabetes Care Inc. · Continuous glucose monitors

Active recall record

Last checked Oct 8, 2026

FreeStyle Libre 3 Continuous Glucose Monitoring System

Abbott Diabetes Care Inc. · Continuous glucose monitors

Active recall record

Last checked Oct 8, 2026

Recent recall records

Class I recallOngoing

FreeStyle Libre 3 Continuous Glucose Monitoring System recall — FDA event 98049

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

FDA · FDA event 98049Posted Jan 14, 2026FreeStyle Libre 3 Continuous Glucose Monitoring System

Class I recallOngoing

FreeStyle Libre 3 Continuous Glucose Monitoring System recall — FDA event 95047

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…

FDA · FDA event 95047Posted Aug 27, 2024FreeStyle Libre 3 Continuous Glucose Monitoring System

Class II recallCompleted

FreeStyle Libre 3 Continuous Glucose Monitoring System recall — FDA event 93393

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…

FDA · FDA event 93393Posted Jan 16, 2024FreeStyle Libre 3 Continuous Glucose Monitoring System

Class II recallOngoing

FreeStyle Libre 2 Continuous Glucose Monitoring System recall — FDA event 92708

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…

FDA · FDA event 92708Posted Aug 17, 2023FreeStyle Libre 2 Continuous Glucose Monitoring System

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Abbott Diabetes Care Inc.

Recent recall records

Class I recallOngoing

FreeStyle Libre 3 Continuous Glucose Monitoring System recall — FDA event 98049

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

FDA · FDA event 98049Posted Jan 14, 2026FreeStyle Libre 3 Continuous Glucose Monitoring System

Class I recallOngoing

Abbott Diabetes Care Inc.

Follow Abbott Diabetes Care Inc.

What MedWatcher tracks

Manufacturer identity and source matching

Sources used for this page

Continuous glucose monitors

FreeStyle Libre 2 Continuous Glucose Monitoring System

FreeStyle Libre 3 Continuous Glucose Monitoring System

Recent recall records

FreeStyle Libre 3 Continuous Glucose Monitoring System recall — FDA event 98049

FreeStyle Libre 3 Continuous Glucose Monitoring System recall — FDA event 95047

FreeStyle Libre 3 Continuous Glucose Monitoring System recall — FDA event 93393

FreeStyle Libre 2 Continuous Glucose Monitoring System recall — FDA event 92708

Abbott Diabetes Care Inc.

Follow Abbott Diabetes Care Inc.

What MedWatcher tracks

Manufacturer identity and source matching

Sources used for this page

Continuous glucose monitors

FreeStyle Libre 2 Continuous Glucose Monitoring System

FreeStyle Libre 3 Continuous Glucose Monitoring System

Recent recall records

FreeStyle Libre 3 Continuous Glucose Monitoring System recall — FDA event 98049

FreeStyle Libre 3 Continuous Glucose Monitoring System recall — FDA event 95047

FreeStyle Libre 3 Continuous Glucose Monitoring System recall — FDA event 93393

FreeStyle Libre 2 Continuous Glucose Monitoring System recall — FDA event 92708