FreeStyle Libre 3 App — Class II medical device recall Z-0734-2024
Completed recall by Abbott Diabetes Care, Inc., reported 2024-01-24, distributed nationwide. If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may b
| Recall number | Z-0734-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Diabetes Care, Inc., Alameda, CA, United States |
| Recall initiated | 2023-02-09 |
| Classified | 2024-01-16 |
| Reported by FDA | 2024-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 45,173 |
| UPC / GTIN / UDI-DI | 00357599816001 |
Product
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0734-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.