Class II recallCompleted

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

FDA · FDA event 93393 · Posted Jan 16, 2024

Published Jan 16, 2024Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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 glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

On 2/9/23, an Important Message/Communication was sent to customers informing them of the following:
If you experience extended periods of signal loss, either of the following actions should allow reconnection: 1) Turn your smartphone's Bluetooth OFF and then ON 2) Turn your smartphone OFF and then ON
To be notified if extended periods of signal loss occur: 1) Open your FreeStyle Libre 3 app, navigate to Alarms, and configure your signal loss alarm to be ON with "Override Do Not Disturb" enabled. 2) Please refer to www.FreeStyleAndroid.com for more information on how to configure alarms.
On 2/27/23, another Important Message/Communication was sent to customers informing them that updated software version 3.4.2 was available to fix the connection issue.
Questions can be directed to Customer Care team at 1-855-632-8658. The team is available 7 days a week from 8 AM to 8 PM Eastern Time, excluding holidays.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This record references FreeStyle Libre 3 Continuous Glucose Monitoring System by Abbott Diabetes Care Inc..

Products affected by FDA event 93393
Model	Description	Lot / serial range	Manufactured	Status
Z-0734-2024	Z-0734-2024	UDI-DI: 00357599816001, Software v.3.4.0 and below	Not provided in the normalized record	Completed

Distribution: US Nationwide distribution in the states of NY, CA, NJ, UT, PA, MS, OH, TX, MN, FL, LA, NE, MI, VA, NC, MA, IN, SC, IA.
Units affected: See official FDA record
Category: Continuous glucose monitors

Timeline

Feb 9, 2023
Recall initiated
Date recorded by the FDA.
Jan 16, 2024
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 93393
Published: Jan 16, 2024
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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

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

FDA · FDA event 93393 · Posted Jan 16, 2024

Published Jan 16, 2024Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

Products affected by FDA event 93393
Model	Description	Lot / serial range	Manufactured	Status
Z-0734-2024	Z-0734-2024	UDI-DI: 00357599816001, Software v.3.4.0 and below	Not provided in the normalized record	Completed

Distribution

US Nationwide distribution in the states of NY, CA, NJ, UT, PA, MS, OH, TX, MN, FL, LA, NE, MI, VA, NC, MA, IN, SC, IA.

Units affected

See official FDA record

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

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

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

Follow FreeStyle Libre 3 Continuous Glucose Monitoring System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

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

Follow FreeStyle Libre 3 Continuous Glucose Monitoring System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline