FDA Alert: Abbott FreeStyle Libre 3 and Libre 3 Plus Continuous Glucose Monitor Recall

Abbott Diabetes Care has announced a Class I medical device recall for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring sensors. A Class I recall is the FDA’s most serious designation and indicates that continued use of the affected devices may cause serious injury or death.

The recall was issued after Abbott identified that some sensors may provide glucose readings that are lower than actual blood glucose levels. If these inaccurate readings go unrecognized, patients may make inappropriate treatment decisions, such as consuming unnecessary carbohydrates or delaying or skipping insulin doses. Over time, these actions can place patients at significant risk for adverse health outcomes.

According to Abbott and the FDA, 860 serious injuries and seven deaths had been reported as of January 7, 2026, in association with this issue. The recall applies only to specific lots of the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors. Libre 3 readers, mobile apps, and other Libre products are not affected.

Patients are advised to immediately stop using any affected sensors and dispose of them. Abbott is offering free replacement sensors for impacted products. Patients can confirm whether their sensor is included in the recall by checking the serial number at www.freestylecheck.com or by contacting Abbott Diabetes Care directly. Health care providers should ensure that patients are informed of the recall and support timely sensor verification and replacement.

During this period, patients are reminded to use a blood glucose meter to guide treatment decisions when sensor readings do not align with symptoms or expectations. Prompt identification and removal of affected sensors is critical to reducing patient harm and maintaining safe diabetes management.