FreeStyle Libre 3 App may lose signal on Android 13 devices
Abbott is recalling FreeStyle Libre 3 App on Android 13 devices due to signal loss that may prevent users from receiving glucose readings and alarms, potentially delaying necessary treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a risk-of-harm medical device where failure to receive glucose readings could result in delayed treatment for dangerous glucose levels. No illnesses or injuries are reported in the source, placing it at High (3) per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Diabetes Care, Inc. is recalling the FreeStyle Libre 3 App, part of a continuous glucose monitoring system, when used on Android 13 Operating System. Software version 3.4.0 and below are affected.
The app may experience extended periods of signal loss when used on Android 13, causing it to disconnect from the monitoring system. When disconnected, users cannot receive glucose readings or alarms. This could result in undetected high or low blood glucose levels.
If glucose levels go undetected, patients may not receive timely treatment. For high glucose levels, insulin may not be taken when required. For low glucose levels, glucose or other treatment may not be taken when required. Delayed treatment for either condition increases the risk of serious health complications.
Users with FreeStyle Libre 3 App version 3.4.0 and below on Android 13 devices should contact Abbott Diabetes Care, Inc. or their healthcare provider for guidance and to determine whether they need to upgrade to a corrected software version or use an alternative glucose monitoring device.
The recalled product
- Product
- FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
- Manufacturer
- Abbott Diabetes Care, Inc.
- Hazard
- signal-loss
- missed-alarms
- delayed-treatment
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00357599816001
- Software v.3.4.0 and below
Distribution
Distributed nationwide across the United States.
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