Communications

(Feb. 6, 2025) –The Food and Drug Administration has identified a class I recall of Abbott's FreeStyle Libre 3 and Libre 3 Plus blood glucose sensors. Class I recalls are the most serious because the device could cause serious injury or death with continued use. Abbott Diabetes Care has issued a letter to distributors, health care providers and affected customers recommending that certain glucose monitor sensors be removed from where they are used or sold:

• FreeStyle Libre 3 Sensor
  • Model Numbers: 72081-01, 72080-01
  • Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002
• FreeStyle Libre 3 Plus Sensor
  • Model Numbers: 78768-01, 78769-01
  • Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014

See the Full list of affected lots.

FreeStyle Libre 3 readers and mobile apps are not affected. Additionally, no other Libre products (FreeStyle Libre 14-day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or Libre Pro sensors) or Abbott biowearables are affected. Patients should verify whether their sensors are affected and immediately discontinue use and dispose of the affected sensor(s).
--Karen Braman