Abbott Diabetes Care has issued a safety warning urging patients to stop using certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitors after internal testing linked the devices to seven deaths and hundreds of adverse events.
The U.S. Food and Drug Administration (FDA) confirmed the recall on Dec. 2, 2025, after Abbott discovered that some sensors may provide incorrect low glucose readings, posing serious health risks. Patients are advised to use a blood glucose meter or the built-in meter on a FreeStyle Libre 3 Reader for treatment decisions when sensor readings are inconsistent with symptoms.
The recall affects approximately 3 million sensors from a single production line in the U.S., about half of which have already been used or expired. The devices have been associated with 736 severe adverse events globally, including 57 in the U.S.
“Incorrect low glucose readings over time may lead to dangerous treatment decisions, such as skipping insulin doses or consuming excessive carbohydrates, potentially resulting in injury or death,” Abbott said.
The company said it has identified the cause of the sensor malfunction, fixed the issue, and will continue to produce Libre 3 and Libre 3 Plus sensors to meet replacement and new orders, with no expected supply disruptions.
