FreeStyle Libre 2 Readers — Class II medical device recall Z-2414-2023
Ongoing recall by Abbott Diabetes Care, Inc., reported 2023-08-23, distributed nationwide. If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for th
| Recall number | Z-2414-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Diabetes Care, Inc., Alameda, CA, United States |
| Recall initiated | 2023-07-12 |
| Classified | 2023-08-17 |
| Reported by FDA | 2023-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 1,722,645 |
| UPC / GTIN / UDI-DI | 00357599803001, 00357599805005 |
| Lot numbers | 01A202D, 01A204D, 01A211D, 01A219D, 01A231D, 01A259D, 01A260D, 01A267D, 01A281D, 01A283D, 01A290D, 01A328D, 01A352D, 01A364D, 01B007F, 01B008F, 01B011F, 01B012F, 01B014F, 01B015F, 01B036F, 01B039F, 01B071F, 01B077F, 01B205D, 01B207D, 01B208D, 01B288D, 01B289D, 01B302F, 01B305D, 01B306D, 01B306F, 01B308D, 01B308F, 01B309D, 01B309F, 01B310D, 01B313D, 01B323F and 383 more |
| Model numbers | 71951-01, 71953-01 |
Product
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Reason for recall
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 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results
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-2414-2023. 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.