FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code:… — Class I medical device recall Z-1021-2026
Ongoing recall by Abbott Diabetes Care, Inc., reported 2026-01-21, distributed in AK, AL, AZ, CA, CO, FL, GA, IA…. Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect
| Recall number | Z-1021-2026 |
|---|---|
| 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 | 2025-11-24 |
| Classified | 2026-01-13 |
| Reported by FDA | 2026-01-21 |
| Distributed | AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WI, WV, WY |
| Countries outside the US | AT, BE, CA, CH, DE, DK, ES, FI, FR, GB, IT, LU, NL, NO, NZ, QA, SE |
| Quantity | 1,663,241 sensors |
| UPC / GTIN / UDI-DI | 00357599844011 |
| Lot numbers | T60003138, T60003243, T60003255 |
| Serial numbers | 0G64THT09, 0G64THT0A, 0G64THT0C, 0G64THT0D, 0G64THT0F, 0G64THT0H, 0G64THT0M, 0G64THT88, 0G64THT89, 0G64THT8A, 0G64THT8C, 0G64THT8G, 0G64THT8K, 0G64THT8M, 0G64THT8P, 0G64THT8Q, 0G64THT8R, 0G64THT8T, 0G64THT8U, 0G64THT8X, 0G64THT8Z, 0G64THT90, 0G64THT91, 0G64THT92, 0G64THT93 and 475 more |
| Model numbers | 78768-01 |
| Expiration dates | 2025-12-31, 2026-01-31 |
Product
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Reason for recall
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low 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-1021-2026. 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.