On November 24, 2025, Abbott announced that it has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some sensors may provide incorrect low glucose readings.
If undetected, incorrect low glucose readings over an extended period may lead to incorrect 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.
Abbott has identified and resolved the cause of the issue, which relates to one production line among several that make Libre 3 and Libre 3 Plus sensors. The company continues to produce Libre 3 and Libre 3 Plus sensors to fulfill replacement and new orders and does not expect significant supply disruptions.
This action involves approximately 3 million Libre 3 and Libre 3 Plus sensors in the U.S. from that production line, about half of which are estimated to have expired or been used. Globally, Abbott has received reports of 736 severe adverse events (57 in the U.S.) and seven deaths (none in the U.S.) potentially associated with this issue.
Important Instructions for People Using Libre 3 or Libre 3 Plus Sensors
Consumers should visit www.FreeStyleCheck.com to confirm whether their sensor is potentially affected by this medical device correction. Abbott will replace any potentially affected sensors at no charge. Detailed instructions on how to check sensors and request a replacement are available on www.FreeStyleCheck.com.
If consumers are currently wearing or have a sensor that has been confirmed as potentially impacted on www.FreeStyleCheck.com or by a customer service representative, they should immediately discontinue use and dispose of it.
Consumers should use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader to make treatment decisions when sensor readings don’t match symptoms or expectations.
FreeStyle Libre 3 readers and mobile apps are not impacted. Additionally, no other Libre products (FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or FreeStyle Libre Pro sensors) or Abbott biowearables are impacted.
Abbott issued this medical device correction in other affected countries where Libre 3 and Libre 3 Plus sensors are distributed. Consumers in other countries can also visit www.FreeStyleCheck.com for more information.
Prior Corrective Action
Over one year ago, on July 24, 2024, Abbott had initiated a voluntary medical device correction for a small number of FreeStyle Libre® 3 sensors distributed in the United States during the first half of May 2024.
The FreeStyle Libre 3 system includes a sensor, reader and app. This medical device correction impacts the sensor only. The FreeStyle Libre 3 reader and app are not impacted.
Internal testing determined that some of the sensors from among three lots may provide incorrect high glucose readings, which if undetected may pose a potential health risk for people living with diabetes and can lead to incorrect treatment decisions, such as taking insulin when not required.
In July 2024, Abbott stated that this issue affects only a small subset of FreeStyle Libre 3 sensors from among those within the following three lot numbers:
T60001969
T60001948
T60001966
We are actively investigating FreeStyle Libre 3 and FreeStyle Libre 3 Plus claims.
If you or a loved one suffered harm as a result of FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensors in the United States that are subject to the medical device correction, visit our website or call us toll-free at 800-295-3959 for a free evaluation of your potential claim.
Turn to us when you don’t know where to turn.