The U.S. Food and Drug Administration (FDA) has issued an early alert regarding malfunctioning glucose monitors from Abbott Diabetes Care, which may be linked to seven deaths and over 700 serious injuries. The alert concerns the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, which may provide incorrect low glucose readings. This issue affects about three million devices, traced back to a single production line.
According to the FDA, these incorrect readings can lead to improper diabetes management, such as excessive carbohydrate intake or delayed insulin doses, posing serious health risks, including potential injury or death. The FDA’s alert, issued on Tuesday (December 2), advises users to immediately stop using the affected sensors and dispose of them.
Abbott Diabetes Care first notified distributors, healthcare providers, and customers about the issue on November 24, 2025. The company identified and resolved the problem and continues to produce new sensors. Abbott has received 736 reports of serious injuries, with 57 occurring in the United States. All seven deaths were reported outside the U.S.
The faulty sensors are designed to provide real-time glucose measurements and transfer data wirelessly to a device or phone. The FreeStyle Libre readers and mobile apps are not affected. Users can check their sensor’s serial number on the app or device and visit freestylecheck.com to verify if their sensor is affected and request a free replacement. Abbott’s customer service is available for assistance at 1-833-815-4273.
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