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FDA-Device2026-01-21Class IPROCESSING DEFECT

Abbott FreeStyle Libre 3 Plus Sensor recalled for potential incorrect low glucose readings

Abbott
OTHERNationwide distribution

Stop using affected FreeStyle Libre 3 Plus sensors

Abbott has recalled certain FreeStyle Libre 3 Plus glucose sensors due to a manufacturing issue 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 is normal or higher. The recall affects specific lot numbers with expiration date of 01/31/2026.

  • Check if your sensor serial number matches the recall list on the FDA website or Abbott's recall notice
  • Stop using the sensor immediately if it matches an affected lot
  • Contact Abbott customer service or your healthcare provider for a replacement sensor
  • In the meantime, use fingerstick testing or another glucose monitoring method as directed by your doctor
  • Do not rely on low glucose alerts from an affected sensor
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
258,913 sensors
Manufactured in
1360 S Loop Rd, Alameda, CA, United States
Products
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 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-1022-2026

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