Data Foundry

Medical device recalls 2026

FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The… — Class I medical device recall Z-1020-2026

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 numberZ-1020-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAbbott Diabetes Care, Inc., Alameda, CA, United States
Recall initiated2025-11-24
Classified2026-01-13
Reported by FDA2026-01-21
DistributedAK, 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 USAT, BE, CA, CH, DE, DK, ES, FI, FR, GB, IT, LU, NL, NO, NZ, QA, SE
Quantity1,060,723 sensors
UPC / GTIN / UDI-DI00357599818005
Lot numbersT60003054, T60003085, T60003089, T60003092, T60003099, T60003113, T60003136, T60003138, T60003159, T60003160, T60003166, T60003169, T60003243, T60003255, T60003271, T60003284
Serial numbers0G4, 0G424K30Z, 0G424K310, 0G424K311, 0G424K313, 0G424K314, 0G424K315, 0G424K316, 0G424K317, 0G424K318, 0G424K319, 0G424K31A, 0G424K31D, 0G424K31G, 0G424K31H, 0G424K31J, 0G424K31L, 0G424K31M, 0G424K31N, 0G424K31Q, 0G424K31R, 0G424K31T, 0G424K31U, 0G424K31V, 0G424K31W and 475 more
Model numbers72081-01
Expiration dates2025-12-31, 2026-01-31

Product

FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 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-1020-2026. 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.