Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the Fr…

Recall date

November 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1020-2026

FDA classification

Class I

Brand / firm

Abbott Diabetes Care, Inc.

Sold / distributed

U.S.: 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, and WY. O.U.S.: Andorra, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, New Zealand, Norway, Qatar, San Mar…

Why it was recalled

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.