FreeStyle Libre Reader — Class I medical device recall Z-1274-2023
Ongoing recall by Abbott Diabetes Care, Inc., reported 2023-04-12, distributed nationwide. Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use
| Recall number | Z-1274-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Diabetes Care, Inc., Alameda, CA, United States |
| Recall initiated | 2023-02-13 |
| Classified | 2023-04-06 |
| Reported by FDA | 2023-04-12 |
| Distributed | Nationwide (US) |
| Quantity | 1,373,311 |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00357599000974, 00357599000981, 00357599002008 |
| Lot numbers | 01A003D, 01A008D, 01A009D, 01A013D, 01A014D, 01A015D, 01A028D, 01A029D, 01A030D, 01A034D, 01A049D, 01A055D, 01A057D, 01A059D, 01A064D, 01A074D, 01A076D, 01A091D, 01A092D, 01A093D, 01A094D, 01A097D, 01A100D, 01A104D, 01A116D, 01A120D, 01A121D, 01A125D, 01A132D, 01A133D, 01A134D, 01A135D, 01A136D, 01A137D, 01A160D, 01A175D, 01A178D, 01A181D, 01A188D, 01A196D and 460 more |
| Model numbers | 71936-01, 71937-01, 71938-01 |
Product
FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
Reason for recall
Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.
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-1274-2023. 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.