Recall issued for certain glucose sensors due to potentially inaccurate readings, FDA says

A voluntary recall has been issued for certain glucose sensors after reports of inaccurate readings.

According to the U.S. Food and Drug Administration, certain FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor devices may show inaccurate readings, posing a potential safety risk to individuals with diabetes.

Specifically, the sensors may display incorrect low-glucose readings, leading to incorrect treatment.

In December 2025, an Early Alert was issued for these specific glucose monitoring systems after Abbott Diabetes Care recommended that they be removed from the market.

The company had become aware of seven deaths and around 736 serious injuries that they believe were connected to the devices.

As of Jan. 7, the number of serious injuries has risen to 860.

If you have these products, the FDA recommends verifying that the sensor is impacted. If it is, the company will send you a free replacement.

The products are sold online through the Abbott Diabetes Care website, Amazon Pharmacy, Walgreens locations and at medical supply stores.

As a note, Freestyle Libre 3 readers, mobile apps and other products are not affected by this recall.

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