FDA shares update about CGM sensor recalls—issue now linked to 860 serious injuries
The U.S. Food and Drug Administration (FDA) has shared additional details about ongoing safety concerns with certain lots of Abbott’s FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.
Back in November 2025, Abbott warned the public that some of its continuous glucose monitoring (CGM) sensors were providing incorrect low glucose warnings. At the time, the FDA was still investigating the issue.
“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,” according to Abbott’s warning. “These decisions may pose serious health risks, including potential injury or death, or other less serious complications.”
In January, the FDA officially confirmed that the CGM sensor issues had resulted in four recalls. They were all Class I recalls, which meant using the sensors in question was associated with a risk of serious injury or death.
Now, the FDA is back with even more information. For example, the number of serious injuries linked to this issue is now 860, up from the previous total of 736. The number of deaths associated with this issue remains unchanged at seven.
The FDA has also provided more information about the lots impacted by these inaccurate sensors. In addition, the agency updated the specifics about the reason for these recalls:
“Abbott Diabetes Care is recalling certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors due to incorrect glucose readings that are lower than actual blood glucose levels,” according to the latest advisory. “If undetected, these 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.”
The recommendations for customers have not changed. FreeStyle Libre 3 readers and mobile apps are not impacted by this issue.
A new statement from Abbott
In the wake of this latest update from the FDA, Abbott shared a fresh statement about the recalls:
"Abbott initiated a medical device correction on Nov. 24, 2025, 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. We immediately contacted customers to make them aware and provide support.
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."
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.