FDA-Device2026-01-21Class IPROCESSING DEFECT
Abbott FreeStyle Libre 3 glucose sensor recalled for incorrect low blood sugar readings
What this means
Abbott is recalling certain FreeStyle Libre 3 sensors due to a manufacturing defect that may cause carbon buildup inside the sensor. This buildup can result in the sensor showing incorrect low blood sugar readings when your actual glucose level is normal or higher. The recall affects sensors with specific lot and serial numbers expiring by December 31, 2025.
- Check your sensor's lot and serial numbers against the recall list at FDA.gov or Abbott's website
- Stop using any recalled sensor and switch to a backup glucose monitoring method immediately
- Contact Abbott customer service at 1-855-632-8658 for a replacement sensor
- Continue monitoring your blood sugar with a fingerstick meter or other device while awaiting a replacement
The agency's original wording
Hazard
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
1,060,723 sensors
Manufactured in
1360 S Loop Rd, Alameda, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1020-2026Want us to check the next one for you?
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