Abbott Diabetes Care Glucose Sensor Recall Designated as ‘Most Serious’

The U.S. Food and Drug Administration said the number of serious injuries linked to the devices had risen to 860.

An exhibit from Abbott is seen at the Las Vegas Convention Center during the Consumer Electronics Show on Jan. 10, 2024. Brendan Smialowski/AFP via Getty Images

The U.S. Food and Drug Administration (FDA) has classified Abbott Diabetes Care’s November 2025 recall of certain glucose monitoring sensors as the “most serious type” and said that the company had reported 860 cases of serious injuries linked to the devices.

Abbott Diabetes Care is a division of Abbott Laboratories.

In a Feb. 2 statement, the FDA noted that it is aware of Abbott’s recall and letter to customers, health care providers, and distributors, and warned of the seriousness of the recall.

“The FDA has identified this recall as the most serious type,” the statement indicated. “This device may cause serious injury or death if someone were to continue using it.”

The company said in November 2025 that it had received reports of 736 severe adverse effects globally, including 57 in the United States, and seven deaths—none in the United States—associated with this issue. As of Jan. 7, the injury cases had increased to 860.

While the affected products have not changed, the full list of affected lots has been modified. The recalled products include the FreeStyle Libre 3 Sensor with model numbers 72081-01 and 72080-01; and the FreeStyle Libre 3 Plus Sensor, with model numbers 78768-01 and 78769-01.

The FDA noted that Freestyle Libre 3 readers and mobile apps are not impacted and no other Libre products are involved in the recall. This includes the Freestyle Libre 14 day, Freestyle Libre 2, FreeStyle Libre 2 Plus, Libre Pro sensors, and Abbott biowearables.

According to the FDA, the recalled sensors may be providing glucose readings that are lower than actual blood glucose levels.

“If undetected, these incorrect glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes,” the statement indicated. For example, an excessive intake of carbohydrates or delay of insulin doses could pose life-threatening health risks.

Patients can verify if their sensors have been affected by visiting www.freestylecheck.com and confirming the sensor serial number on the app, reader, or label on the bottom of the sensor applicator or carton. If their sensors have been recalled, they should immediately discontinue use and discard them.

Consumers can request replacements for any affected sensors using the same website. The FDA recommends patients use a blood glucose meter or the built-in meter in the Freestyle Libre 3 Reader to make any treatment decisions when sensors do not match symptoms or expectations.

Healthcare providers are being urged to inform their patients, instructing them to visit the website to determine if their sensors have been affected.

Both the FreeStyle Libre 3 and FreeStyle Libre 3 Plus Continuous Glucose Monitoring Systems operate in real time to provide continuous monitoring of glucose. They are equipped with alarms to manage diabetes in those aged four and older. The devices are intended to replace blood glucose testing for the disease.

In addition to tracking trends and patterns, the systems also detect any episodes of hyperglycemia, or high blood sugar, and hypoglycemia, or low blood sugar.  When there’s an excess of glucose in the blood, symptoms can include increased thirst, fatigue, and blurred vision. Conversely, insufficient glucose can cause shakiness, dizziness, sweating, confusion, and a rapid heart rate.

According to the American Diabetes Association, more than 38 million children and adults in the United States have diabetes. In 2022, the national cost of diabetes was estimated to be more than $412.9 billion, up from $327 billion in 2017.

Based in Alameda, California, Abbott Diabetes Care is a global leader in diabetes management serving patients throughout North and South America, Europe, and Asia.