FDA Sounds Alarm as Faulty Abbott’s FreeStyle Libre Glucose Sensors Linked to 7 Deaths and 736 Injuries Across America
Nikhil Prasad Fact checked by:Thailand Medical News Team Dec 05, 2025 46 minutes ago
Medical News: Recall of FreeStyle Libre Glucometer Devices Impacts Millions
In a major public health alert, the U.S. Food and Drug Administration (FDA) has issued an urgent warning following the discovery that faulty glucose sensor devices produced by Abbott Diabetes Care have been linked to at least seven deaths and over 736 serious injuries across America. The devices in question—FreeStyle Libre 3 and FreeStyle Libre 3 Plus—are widely used continuous glucose monitors (CGMs) that help millions of individuals with diabetes manage their blood sugar levels. Approximately three million of these devices are affected by the issue.
Abbott's faulty glucose sensors prompt global recall after seven deaths and hundreds of injuries in America
This
Medical News report highlights that the FDA considers the situation a “potentially high-risk” issue. The recall includes only the FreeStyle Libre 3 and 3 Plus sensors. No other Libre models are involved.
The Danger of False Readings
The faulty sensors have been found to provide incorrect low glucose readings. This error can have grave consequences. Individuals using these monitors may wrongly assume they are experiencing dangerously low blood sugar levels and overcompensate by consuming excess carbohydrates or skipping their insulin doses. Over time, such repeated misjudgments can lead to severe health outcomes, including injury or even death.
According to Abbott, seven deaths have been reported outside the United States, while 736 serious injuries—have been documented. The company identified the issue as a manufacturing flaw that has since been resolved. Nonetheless, the FDA is urging users to immediately stop using the affected devices and to dispose of them properly.
How to Know if Your Device Is Affected
The affected model numbers and unique device identifiers (UDI-DIs) are as follows:
FreeStyle Libre 3 Sensor:
Model Numbers: 72081-01, 72080-01
UDI-DIs: 00357599818005, 00357599819002
FreeStyle Libre 3 Plus Sensor:
Model Numbers: 78768-01, 78769-01
UDI-DIs: 00357599844011, 00357599843014
Users can locate the serial numbers on their sensor packaging, the reader, or through the FreeStyle Libre 3 app. Abbott has created a dedicated website—www.FreeStyleCheck.com—where users can verify if their sensor is affected and request a free replacement. Customers are also encouraged to report any adverse effects to the FDA via the MedWatch Safety Information and Adverse Event
Reporting Program.
Abbott’s Response and Ongoing Production
Abbott stated in its press release that the underlying cause of the malfunction was promptly identified and resolved. The company continues to produce Libre 3 and Libre 3 Plus sensors to meet replacement demand and fulfill new orders without expected delays. Customers have been notified through various
channels, and replacements will be shipped at no charge.
Abbott emphasized the importance of using an alternative blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader for making treatment decisions if the sensor readings do not align with physical symptoms.
Millions at Risk Amid Diabetes Epidemic
With diabetes affecting over 38 million people in the U.S. alone, devices like continuous glucose monitors play a critical role in disease management. They provide real-time glucose readings, alert patients to dangerous highs or lows, and eliminate the need for frequent finger-prick tests. However, this latest recall casts a shadow over the reliability of such tools.
The FDA’s warning signals not only the urgent need for users to check their devices but also raises broader concerns over quality control in life-saving medical technologies. Both the FDA and Abbott advise caution and immediate action for those affected.
In light of the alert, healthcare professionals are also urged to remain vigilant and guide their patients accordingly. While the problem has been corrected, the fallout continues, and regulatory updates are expected as investigations proceed.
These faulty sensors serve as a grim reminder of how even a small error in a medical device can lead to tragic consequences on a global scale. Vigilance, accountability, and swift consumer action are now more vital than ever in mitigating harm.
Other Countries Need to Also take Action.
It is believed that Abbot Freestyle Libre devices distributed in other parts of the world including Europe, Middle-East, Australia and New Zealand are also affected, Health officials and regulatory agencies in these countries need to act fast and all users should stop using their devices and switch to alternative brands. Consumers affected by these devices should consult their lawyers immediately to begin legal suits against Abbott, their distributors and also medical doctors who had recommended these devices and also various regulatory agencies in their countries.
References:
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-glucose-monitor-sensor-issue-abbott-diabetes-care
https://abbott.mediaroom.com/press-releases?item=124718
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