PlainRecalls
FDA Devices Critical Class I Ongoing

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.

Reported: January 21, 2026 Initiated: November 24, 2025 #Z-1020-2026

Product Description

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

Details

Units Affected
1,060,723 sensors
Distribution
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 Marino, Spain, Sweden, Switzerland, and United Kingdom.
Location
Alameda, CA

Frequently Asked Questions

What product 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.. Recalled by Abbott Diabetes Care, Inc.. Units affected: 1,060,723 sensors.
Why was this product recalled?
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Which agency issued this recall?
This recall was issued by the FDA Devices on January 21, 2026. Severity: Critical. Recall number: Z-1020-2026.