|
|
Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and 3 Plus Sensors
The FDA is aware that Abbott Diabetes Care is recalling certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors due to incorrect glucose readings that are lower than the actual blood glucose levels. If undetected, incorrect (lower than actual) glucose readings over an extended period may lead to wrong 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.
This recall was previously communicated as an Early Alert on December 1, 2025. Since then, Abbott has reported additional adverse events. As of January 7, 2026, Abbott has reported a total of 860 serious injuries and seven deaths associated with this issue. The affected products have not changed, but the list of affected lots has been modified for clarity. The recommendations for what to do with the recalled devices has not changed, and the reason for the recall has been clarified and updated with current information.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abbott Diabetes Care at 1-833-815-4273 or https://www.freestyle.abbott/us-en/support/contact-us.html.
|
|
|
|
