The Food and Drug Administration (FDA) has announced a “most serious type” recall for certain glucose monitor sensors, warning that continued use could result in serious injury or death.

In its statement, the FDA emphasized: “This device may cause serious injury or death if you continue to use it.”

The agency identified that some models of FreeStyle Libre 3 and FreeStyle Libre 3 Plus were previously recalled in December due to sensors providing incorrect low glucose readings. The current recall addresses an expanded issue affecting additional devices.

The FDA reported that Abbott Diabetes Care has issued a letter to distributors, healthcare providers, and affected customers recommending the removal of certain glucose monitor sensors from where they are used or sold.

The recalled sensors may provide glucose readings lower than actual blood glucose levels. If these inaccuracies go undetected over time, they could lead to improper treatment decisions for individuals with diabetes—including excessive carbohydrate intake or skipping insulin doses. Such errors pose serious health risks, including potential injury or death.

As of January 7, 2026, Abbott Diabetes Care has reported 860 serious injuries and seven deaths associated with this issue.

The FreeStyle Libre 3 and FreeStyle Libre 3 Plus Continuous Glucose Monitoring Systems are designed for individuals aged four and older. These devices replace blood glucose testing for diabetes management decisions and detect trends to help identify episodes of hyperglycemia and hypoglycemia.

Patients can determine if their sensor is affected by visiting www.freestylecheck.com and selecting “CONFIRM SENSOR SERIAL NUMBER.” The serial number for the FreeStyle Libre 3 sensor or a FreeStyle Libre 3 Plus sensor can be found in the app, reader, and on the label at the bottom of the sensor applicator.

Abbott Diabetes Care has stated that it identified the cause to one production line among several manufacturing sites. The company continues to produce sensors for replacements and new orders without significant supply disruption.

Customers in the U.S. experiencing adverse reactions or quality issues should contact Abbott Diabetes Care at 1-833-815-4273 or visit www.freestyle.abbott/us-en/support/contact-us.html.