FDA-Device2026-01-21Class IPROCESSING DEFECT
Abbott FreeStyle Libre 3 Plus Sensor recalled for potential incorrect low glucose readings
OTHERNationwide distribution
Stop using recalled FreeStyle Libre 3 Plus sensors
Abbott Diabetes Care is recalling certain FreeStyle Libre 3 Plus continuous glucose monitoring sensors due to a manufacturing issue that may cause carbon buildup inside the sensor. This buildup could lead to incorrect low blood sugar readings, which may not alert you when your glucose is actually low.
- Check if your sensor's serial number matches the recall list (contact Abbott or your healthcare provider with your sensor serial number)
- Do not rely solely on affected sensors for diabetes management decisions
- Contact Abbott Diabetes Care or your healthcare provider for a replacement sensor
- Continue monitoring blood sugar with alternative methods (fingerstick testing) until you receive a replacement
Hazard
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
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
8,062 sensors
Manufactured in
1360 S Loop Rd, Alameda, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1023-2026Don't want to check this manually?
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