The FDA has issued an Early Alert regarding a serious issue with certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring sensors manufactured by Abbott Diabetes Care. These specific sensors (model numbers 72081-01, 72080-01, 78768-01, and 78769-01, with listed UDI-DI codes) from affected lots may display incorrectly low glucose readings, which, if undetected over time, could lead patients to make dangerous treatment errors such as over-consuming carbohydrates or skipping insulin doses.

This has been linked to 736 reported serious injuries and seven deaths as of November 14, 2025. FreeStyle Libre 3 readers, mobile apps, and all other Libre products are not affected.

Patients are urged to immediately check their sensors at www.freestylecheck.com by entering the sensor serial number (found on the applicator, carton, app, or reader) to determine if it is impacted. Anyone currently wearing or possessing an affected sensor should stop using it at once, dispose of it safely, and request free replacements through the same website. Until a replacement is received, patients should rely on a traditional blood glucose meter or the built-in meter in the FreeStyle Libre 3 Reader for treatment decisions if readings seem inconsistent with symptoms.

Health care providers and distributors have been instructed to notify patients, remove affected inventory, and arrange returns and replacements. The FDA is actively reviewing the high-risk issue and will provide updates as new information becomes available. Patients with questions can contact Abbott at 1-833-815-4273.