Full Breakdown
Abbott Diabetes Care Issues Urgent Recall of Glucose Monitor Sensors
12/6/2025, 11:19:24 AM
Overview of the Recall
The U.S. Food and Drug Administration (FDA) has issued a warning regarding certain glucose monitor sensors produced by Abbott Diabetes Care, following reports linking these devices to seven deaths and over 700 injuries globally. The affected products, specifically the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, may provide inaccurate low glucose readings, which can lead to dangerous treatment decisions for individuals with diabetes.
Scope of the Issue
Approximately three million sensors distributed in the U.S. are affected by this recall, originating from a single production line. Abbott reported that about half of these sensors have either expired or already been used. The FDA's alert emphasizes that incorrect low glucose readings can lead to serious health risks, including excessive carbohydrate intake or delayed insulin doses, potentially resulting in severe complications or death.
Identifying Affected Devices
The specific model numbers for the affected FreeStyle Libre 3 sensors are 72080-01 and 72081-01, with unique device identifiers 00357599818005 and 00357599819002. For the FreeStyle Libre 3 Plus sensors, the model numbers are 78768-01 and 78769-01, with unique device identifiers 00357599844011 and 00357599843014. Consumers are advised to check their sensor serial numbers at [FreeStyleCheck.com](http://www.FreeStyleCheck.com) to determine if their devices are impacted and to request replacements.
Official Statements & Responses
Abbott Diabetes Care has communicated with customers regarding the recall, advising them to stop using the affected sensors immediately. The company has stated that it has identified and resolved the production issue associated with the affected lot. Abbott emphasized that no other FreeStyle Libre products are impacted by this recall.
The FDA described the situation as a "potentially high-risk issue" and urged users to discontinue the use of the faulty sensors. Abbott has also reported that all seven deaths linked to the sensors occurred outside the U.S., with 57 injuries documented domestically.
Criticism & Opposition
While Abbott has taken steps to address the issue, some critics have raised concerns about the adequacy of the company's response and the potential risks posed to patients relying on these devices for glucose monitoring. The FDA's alert highlights the importance of immediate action in such cases, suggesting that the situation could have been managed more effectively to prevent adverse outcomes.
What's Next
Abbott has indicated that it will continue to produce new sensors and does not anticipate significant supply disruptions. The company is committed to providing replacements for affected devices at no charge and has urged users to consult healthcare providers for alternative monitoring methods in the interim.
Verbatim Quotes
“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 Diabetes Care
“The FDA said people should stop using affected sensors and discard them.” — FDA Official Statement
“If undetected, incorrect low 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,” — FDA Alert
“contacted customers to make them aware and provide support,” — Abbott Diabetes Care
