Medical device recalls High risk

Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component…

Recall date
November 24, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1023-2026
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 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

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