FDA Issues Alert After Seven Deaths Linked to Abbott FreeStyle Libre 3 Glucose Monitor Defects
核心洞察
The FDA has issued an urgent alert after Abbott reported seven deaths and 736 serious injuries associated with defective FreeStyle Libre 3 (搜索) and FreeStyle Libre 3 Plus (搜索) glucose monitoring sensors that provide incorrect low glucose readings.
The affected sensors may lead to dangerous treatment decisions including excessive carbohydrate intake or delayed insulin doses, posing serious health risks to diabetes (搜索) patients.
Abbott has initiated a recall of specific sensor models and is providing free replacements to affected customers through their verification website.
The Food and Drug Administration has issued an urgent medical device alert following reports of seven deaths and 736 serious injuries linked to defective Abbott FreeStyle Libre 3 (搜索) glucose monitoring sensors that provide incorrect low glucose readings. As of November 14, 2025, Abbott Diabetes Care has reported these adverse events associated with specific models of FreeStyle Libre 3 and FreeStyle Libre 3 Plus (搜索) sensors.
Critical Safety Issue
The affected sensors are providing incorrect low glucose readings, which can lead to dangerous treatment decisions for diabetes (搜索) patients. According to the FDA, if these incorrect readings go undetected over an extended period, patients may make wrong treatment choices 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.
Affected Products
The recall specifically targets the following sensor models:
FreeStyle Libre 3 (搜索) Sensor:
- Model Numbers: 72081-01, 72080-01
- Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002
FreeStyle Libre 3 Plus (搜索) Sensor:
- Model Numbers: 78768-01, 78769-01
- Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014
The FDA emphasizes that FreeStyle Libre 3 (搜索) readers and mobile apps are not impacted by this issue. Additionally, no other Libre products including FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or Libre Pro sensors, or Abbott biowearables are affected.
Patient Action Required
On November 24, 2025, Abbott Diabetes Care sent letters to all affected customers with specific instructions. Patients can determine if their current or unused sensors are affected by visiting www.freestylecheck.com and selecting "CONFIRM SENSOR SERIAL NUMBER."
For patients wearing FreeStyle Libre 3 (搜索) or FreeStyle Libre 3 Plus (搜索) sensors, the serial number can be found in the app or reader, as well as on the label on the bottom of the sensor applicator or carton. Patients who confirm their sensors are potentially affected must immediately discontinue use and dispose of the affected sensors.
Abbott is providing free replacement sensors for any potentially affected devices through their verification website. Patients can request replacements at no cost by entering their contact information on the same platform.
Healthcare Provider Guidance
The FDA is instructing healthcare providers to inform their patients about this critical safety issue. Providers should direct patients to visit the verification website to confirm if their sensors are impacted and ensure immediate discontinuation of affected devices.
Healthcare providers are also advised to instruct patients to use a blood glucose meter or the built-in meter in their FreeStyle Libre 3 (搜索) Reader to make treatment decisions when sensor readings don't match symptoms or expectations.
Device Background
The FreeStyle Libre 3 (搜索) and FreeStyle Libre 3 Plus (搜索) Continuous Glucose Monitoring Systems are real-time continuous glucose monitoring devices with alarm capability indicated for diabetes (搜索) management in persons age four and older. These devices are intended to replace blood glucose testing for diabetes treatment decisions and can detect trends and track patterns to aid in the detection of hyperglycemia (搜索) and hypoglycemia (搜索) episodes.
The systems are designed to autonomously communicate with digitally connected devices and can be used alone or in conjunction with these devices where users manually control actions for therapy decisions.
Customers in the United States with adverse reactions, quality problems, or questions about this recall should contact Abbott Diabetes Care at 1-833-815-4273.