FDA Classifies Abbott FreeStyle Libre 3 Sensor Recall as Class I After 860 Serious Injuries

The US Food and Drug Administration has classified Abbott Diabetes Care's removal of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitor sensors as a Class I recall, the agency's most serious type. The FDA updated its notice on February 4 to announce the classification, and said Abbott had reported 860 serious injuries and seven deaths associated with the issue as of January 7, 2026.

The recall covers FreeStyle Libre 3 sensors with model numbers 72081-01 and 72080-01 and FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01. According to the FDA, Libre 3 readers and mobile apps are not affected, and no other Libre products, including FreeStyle Libre 14 day, Libre 2, Libre 2 Plus and Libre Pro sensors, are part of the action.

Readings lower than actual glucose

The FDA said Abbott is recalling the sensors "due to incorrect glucose readings that are lower than actual blood glucose levels." According to the notice, if undetected over an extended period, the low readings may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses, which may pose serious health risks including potential injury or death.

The FDA first flagged the problem in an Early Alert on December 2, 2025, according to the notice's timeline. Abbott sent affected customers a letter on November 24, 2025, recommending that people check whether their sensors are affected through the company's FreeStyleCheck.com site, stop using and dispose of affected sensors, and request free replacements, the FDA said. Abbott also told customers to use a blood glucose meter or the meter built into the Libre 3 reader for treatment decisions when sensor readings do not match symptoms or expectations.

The American Hospital Association's news service reported the Class I designation on February 4.

One production line, about 3 million US sensors

When it announced the action in November, Abbott said internal testing had found that some sensors may give incorrect low glucose readings, and that it had identified and resolved the cause, which "relates to one production line among several that make Libre 3 and Libre 3 Plus sensors." The company said the correction involved approximately 3 million Libre 3 and Libre 3 Plus sensors in the United States from that line, about half of which it estimated had already expired or been used.

At that time, Abbott said it had received reports globally of 736 severe adverse events, 57 of them in the US, and seven deaths, none in the US, potentially associated with the issue. The FDA's figure of 860 serious injuries is dated January 7, 2026. Abbott said in November that it continued to produce Libre 3 and Libre 3 Plus sensors to fill replacement and new orders and did not expect significant supply disruptions, and that it was taking the same action in other countries where the sensors are distributed.

According to the FDA, the Libre 3 and Libre 3 Plus systems are real-time continuous glucose monitoring devices with alarms, indicated for managing diabetes in people aged four and older, and are intended to replace blood glucose testing for treatment decisions unless otherwise indicated. The notice says the systems are also intended to communicate autonomously with digitally connected devices.