Abbott FreeStyle Libre 3 Recall Issued After Faulty Glucose Sensor Readings Linked to Multiple Deaths

Manufacturer is advising customers to stop using the devices immediately and resort to other means of monitoring glucose levels.

Abbott is warning that more than 3 million FreeStyle Libre 3 and Libre 3 Plus sensors may provide inaccurate readings, which could lead to unnecessary insulin dosing, fainting episodes, emergency room visits and potentially fatal complications.

The Abbott FreeStyle Libre 3 recall was announced in a press release on November 24, following more than 700 reports of serious health consequences linked to devices producing falsely low results.

Glucose sensors are small devices worn on the upper arm that continuously track blood sugar levels, a critical tool for people with diabetes who rely on real-time data to avoid dangerous highs and lows. By showing current levels and trends, the sensors help users adjust medication, food intake and daily activity.

However, the manufacturer reports that internal testing of certain FreeStyle Libre 3 units found that some may generate undetected false lows for extended periods. This can mislead users into taking insulin they do not need, increasing the risk of severe hypoglycemia, confusion, loss of consciousness and other life-threatening complications.

Abbott indicates that it has received at least 736 severe adverse event reports globally involving problems with the FreeStyle Libre 3, with 57 occurring in the U.S. At least seven deaths may have resulted from complications caused by the false readings.

The current recall impacts approximately 3 million Abbott FreeStyle Libre 3 and Libre 3 Plus sensors in the U.S., about half of which are estimated to have already expired or been used. 

Consumers are being instructed to visit www.FreeStyleCheck.com to determine whether their sensor is affected and to request a replacement. Libre 3 readers and mobile apps are not impacted by this action. 

If consumers are currently wearing or have an affected sensor, Abbott advises them to stop using it immediately and dispose of it properly. The company reports that the underlying issue has been identified and resolved, and it is continuing to manufacture Libre 3 and Libre 3 Plus sensors for replacements and new orders. 

Consumers are advised to use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader to guide treatment decisions when sensor readings do not match symptoms or expectations.

For more information, customers can visit www.FreeStyleCheck.com or call Abbott customer service at 1-833-815-4273, which is available seven days a week from 8 a.m. to 8 p.m. ET.

FreeStyle Libre 3 Recall Lawsuits

Following the recall, attorneys are now investigating FreeStyle Libre 3 lawsuits for individuals and families who suffered injuries or wrongful death caused by incorrectly low glucose readings. 

You may qualify for a Libre 3 recall lawsuit if you or a loved one used a recalled FreeStyle Libre 3 or Libre 3 Plus sensor and suffered serious injuries after relying on inaccurate glucose readings, including:

• Wrongful Death
• Severe hypoglycemia
• Seizures
• Confusion or altered mental state
• Loss of consciousness
• Diabetic ketoacidosis
• Other acute metabolic emergencies
• Emergency medical treatment or hospitalization

To determine whether you or a family member may qualify for a FreeStyle Libre 3 lawsuit, submit your information for a free case evaluation. An attorney can review your case, explain your legal rights, and pursue a claim if eligible.

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