The Food and Drug Administration (FDA) issued a stark warning Tuesday about malfunctioning blood glucose monitoring devices that may have contributed to seven deaths and hundreds of serious injuries.
Medical equipment manufacturer Abbott also alerted users and health distributors last Monday, urging them to immediately stop using or dispose of all FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor devices.
The FDA described the issue as a “potentially high-risk” problem.
“As of November 14, 2025, Abbott has reported 736 serious injuries and seven deaths associated with this issue,” the FDA said. Abbott noted that 57 of the “severe adverse events” occurred in the U.S., and none of the deaths took place in the country.
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Both the FDA and Abbott warned that the monitors may “provide incorrect low glucose readings” and advised patients to check whether their sensors are affected.
“Abbott initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the U.S. after internal testing determined that some of these sensors may provide incorrect low glucose readings,” Abbott told FOX Business Tuesday.
“If undetected, incorrect low glucose readings over an extended period may lead to improper treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses,” the FDA and Abbott said. “These decisions can pose serious health risks, including potential injury or death, as well as other less severe complications.”
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The sensors involved are real-time monitoring devices with alarm capabilities, designed to help manage diabetes in individuals aged four and older.
Abbott said the company has identified and resolved the manufacturing issue related to these devices, noting that the problem affects only one production line out of several used to make the sensors. Approximately 3 million sensors from the affected line are impacted, the company said.
The manufacturer said it will produce new devices to fulfill replacement and new orders and that the company does not expect significant supply disruptions.
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| ABT | ABBOTT LABORATORIES | 126.32 | -1.75 | -1.37% |
Consumers can visit www.FreeStyleCheck.com to determine if their sensors are affected and to obtain a replacement at no charge, Abbott added.
The company emphasized that no other Libre family sensors, readers or apps are affected.
Fox News Digital reached out to the FDA for more information.
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