December 5, 2025: Abbott Diabetes Care has initiated an urgent medical device correction affecting approximately 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring sensors in the United States. The FDA issued an Early Alert on November 24, 2025, following reports of serious injuries and deaths linked to incorrect glucose readings from the affected devices.
What is an FDA Early Alert? These alerts notify the public about potentially high-risk device removals or corrections before the FDA has completed its full regulatory review. The goal is to minimize the time between the FDA's awareness of a serious issue and public notification, ensuring patients and healthcare providers can take immediate protective action.
According to Abbott's press release, the company has received 736 reports of severe adverse events, including 57 in the United States, and seven deaths potentially associated with this issue. None of the reported deaths occurred in the U.S.
The problem stems from certain sensors providing incorrect low glucose readings.
When undetected over extended periods, these false readings can lead diabetes patients to make dangerous treatment decisions, such as consuming excessive carbohydrates or skipping insulin doses. These incorrect actions may result in serious health complications, injury, or even death.
Abbott has identified the root cause of the problem, which was traced to a single production line among several manufacturing FreeStyle Libre 3 and Libre 3 Plus sensors. The company reports that the manufacturing issue has been resolved and production continues on other lines to fulfill replacement orders and new prescriptions without significant supply disruptions.
Of the approximately 3 million affected sensors in the U.S., Abbott estimates that roughly half have already expired or been used.
The recall specifically impacts:
FreeStyle Libre 3 Sensor (Model Numbers: 72081-01, 72080-01)
FreeStyle Libre 3 Plus Sensor (Model Numbers: 78768-01, 78769-01)
Importantly, FreeStyle Libre 3 readers and mobile apps are not affected. Other products in the Libre family, including FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, and Libre Pro sensors, as well as other Abbott biowearables, are also not impacted.
What is a Medical Device Recall? The FDA uses the term "recall" when a manufacturer takes corrective action to address a problem with a medical device that violates FDA law. This can involve either a correction (addressing the problem where the device is used or sold) or a removal (taking the device away from where it's used or sold). Recalls occur when devices are defective, pose health risks, or both.
Patients using FreeStyle Libre 3 or Libre 3 Plus sensors should take the following steps:
Visit www.FreeStyleCheck.com and select "CONFIRM SENSOR SERIAL NUMBER" to determine if their current or unused sensors are affected
If wearing an affected sensor, immediately discontinue use and dispose of it properly
Patients can request a replacement for any potentially affected sensor(s) on www.FreeStyleCheck.com
The FDA recommends that healthcare providers inform their diabetes patients about this correction immediately. Patients should be directed to check their sensors online and discontinue use of any affected devices.
For questions or to report adverse events, patients can contact Abbott's customer service at 1-833-815-4273 or through https://www.freestyle.abbott/us-en/support/contact-us.html.
This medical device correction is being issued globally in all countries where FreeStyle Libre 3 and Libre 3 Plus sensors are distributed.
(Rh/VK/MSM)