The Food and Drug Administration has declared a “most serious type” recall for certain Abbott Diabetes Care glucose monitor sensors, warning that continued use could lead to serious injury or death.
In its official statement, the FDA emphasized that these devices may provide incorrect low glucose readings. If undetected over an extended period, such inaccuracies might result in patients consuming excessive carbohydrates or delaying or skipping insulin doses—decisions that could cause severe health complications, including potential injury or death.
The recall specifically targets some models of Abbott’s FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring systems. As of January 7, 2026, the FDA has documented 860 serious injuries and seven deaths associated with this issue.
According to the FDA, the affected sensors were identified in December after internal testing by Abbott revealed that certain production units could produce false low readings. The company has since resolved the problem and continues to manufacture the devices for replacements and new orders without significant supply disruptions.
Patients are urged to check if their current or unused sensors are impacted by visiting www.freestylecheck.com and entering their sensor’s serial number, which can be found in the app, reader, or on the label of the sensor applicator. Affected sensors must be discontinued immediately and disposed of properly.
Those experiencing adverse reactions, quality issues, or questions should contact Abbott Diabetes Care at 1-833-815-4273 or via their support website.
