FDA Warns 3 Million FreeStyle Libre 3 and Libre 3 Plus Sensors Impacted by Massive Abbott Recall

Lawsuits are now being filed, claiming Libre 3 sensors produced inaccurately low glucose readings that may have led users to administer unnecessary insulin, raising the risk of hypoglycemia and related health emergencies.

Federal regulators have announced a Class I recall of approximately 3 million Abbott FreeStyle Libre 3 and Libre 3 Plus continuous glucose monitor sensors, following multiple deaths associated with inaccurate readings.

The U.S. Food and Drug Administration (FDA) announced the Abbott FreeStyle Libre 3 recall on January 15, after receiving more than 700 reports of serious health events linked to sensors that displayed falsely low glucose readings, creating a risk of improper insulin dosing, loss of consciousness, emergency medical intervention, and other potentially life-threatening complications.

Glucose monitor sensors are wearable devices, typically placed on the upper arm, that provide continuous readings of blood sugar levels. They play an essential role for people with diabetes by offering real-time information that helps guide insulin use, diet and daily activity to prevent dangerous glucose fluctuations.

According to an Abbott recall originally announced by the manufacturer on November 24, internal testing has revealed that some FreeStyle Libre 3 sensors may display inaccurately low glucose readings for prolonged periods without alerting users.

These false readings have led to a growing number of Abbott Libre 3 lawsuits, which claim the sensor defect could prompt unnecessary insulin use, increasing the risk of severe hypoglycemia, disorientation, fainting and other serious health emergencies.

Abbott says that it has received at least 736 worldwide reports of serious adverse events linked to problems with the FreeStyle Libre 3 system, including 57 cases in the U.S. The company also indicates that at least seven deaths may be associated with complications stemming from inaccurate low glucose readings.

The FDA Class I recall affects an estimated 3 million FreeStyle Libre 3 and Libre 3 Plus sensors, although the manufacturer says that roughly half of those units have already been used or have expired. Consumers are being directed to check whether their sensor is included in the recall by visiting www.FreeStyleCheck.com, where they can also request a replacement.

Class I recalls are the most serious type of recall, which indicate that the FDA has determined use of the product poses a reasonable probability of serious injury or death.

The current recall does not apply to Libre 3 readers, any of the related mobile applications, or other Libre-branded products, including the FreeStyle Libre 14 Day, FreeStyle Libre 2, FreeStyle Libre 2 Plus or Libre Pro sensors.

Abbott is advising anyone currently using an affected sensor to immediately stop and properly discard the device. The company states it has identified and corrected the underlying issue and continues to manufacture Libre 3 and Libre 3 Plus sensors to meet replacement needs and fulfill new orders. Users are also encouraged to rely on a traditional blood glucose meter, or the built-in meter in the Libre 3 reader, when sensor readings do not align with symptoms or expectations.

Additional information is available through Abbott’s website, by contacting customer service at 1-833-815-4273, which is staffed seven days a week from 8 a.m. to 8 p.m. ET, or via live chat 24/7 at https://www.freestyle.abbott/us-en/support/contact-us.html.

This marks at least the second significant recall involving FreeStyle Libre devices in recent years. Abbott recalled approximately 4.2 million FreeStyle Libre glucose monitors in April 2023, after receiving more than 200 reports of batteries overheating, which were linked to fires and at least one reported burn injury.

FreeStyle Libre 3 Recall Lawsuits

In the wake of the recall, attorneys are reviewing FreeStyle Libre 3 lawsuits on behalf of individuals who suffered serious injuries or wrongful death after relying on falsely low glucose readings.

Individuals may be eligible to pursue a claim if they or a loved one used a recalled FreeStyle Libre 3 or Libre 3 Plus sensor and experienced any of the following severe health complications:

• Wrongful death
• Extreme hypoglycemia
• Seizures
• Confusion or altered mental status
• Loss of consciousness
• Diabetic ketoacidosis
• Other acute metabolic emergencies
• Hospitalization

Free case evaluations are available to help determine whether an Abbott FreeStyle Libre 3 lawsuit may be appropriate. An attorney can review the circumstances, explain potential legal options and assess whether a claim may be pursued.

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