FDA Recalls Certain FreeStyle Libre 3 Glucose Sensors After 7 Deaths, 860 Injuries

The recall affects specific models of FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors due to incorrect low glucose readings.

Feb. 4, 2026 at 3:55pm

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The Food and Drug Administration (FDA) has now identified the recall of certain FreeStyle Libre glucose monitor sensors as 'most serious' and is warning that using the recalled device may cause serious injury or death. As of January 7, 2026, Abbott Diabetes Care has reported 860 serious injuries and seven deaths associated with some models of FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.

Why it matters

The FDA says if undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.

The details

In December, the FDA issued an alert for after certain FreeStyle Libre glucose monitor sensors are providing incorrect low glucose readings. The affected models are the FreeStyle Libre 3 Sensor (Model Numbers: 72081-01, 72080-01; Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002) and the FreeStyle Libre 3 Plus Sensor (Model Numbers: 78768-01, 78769-01; Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014).

  • In December, the FDA issued an alert for the recall of certain FreeStyle Libre glucose monitor sensors.
  • As of January 7, 2026, Abbott Diabetes Care has reported 860 serious injuries and seven deaths associated with some models of FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.

The players

FDA

The Food and Drug Administration, the federal agency responsible for protecting public health by regulating food, drugs, medical devices, and more.

Abbott Diabetes Care

The medical device company that manufactures the FreeStyle Libre line of glucose monitoring systems.

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What’s next

Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor(s). Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abbott Diabetes Care at 1-833-815-4273 or www.freestyle.abbott/us-en/support/contact-us.html.

The takeaway

This recall highlights the importance of closely monitoring medical devices and the potential risks they pose if they malfunction. Patients relying on glucose monitoring systems should be vigilant in verifying their devices are not subject to any recalls that could put their health at serious risk.