FreeStyle Libre 3 Recall Lawsuit Alleges Abbott Sold Defective Glucose Sensors

Recall was issued after Abbott received hundreds of reports involving serious injuries and several deaths potentially linked to inaccurate glucose readings.

A Connecticut man has filed a class action lawsuit alleging Abbott sold defective FreeStyle Libre 3 glucose sensors that provided dangerously inaccurate readings and exposed users to serious health risks.

The complaint (PDF) was brought by Gary Horn in the U.S. District Court for the Northern District of Illinois on September 3, naming Abbott Laboratories and Abbott Diabetes Care Inc. as defendants.

Horn claims the companies knew about manufacturing problems affecting FreeStyle Libre 3 sensors but continued marketing the continuous glucose monitoring system as accurate, reliable and capable of replacing routine fingerstick testing.

FreeStyle Libre 3 Recalls

FreeStyle Libre 3 and FreeStyle Libre 3 Plus are wearable continuous glucose monitors that provide glucose readings throughout the day to help users manage diabetes and make insulin dosing decisions.

In July 2024, Abbott announced a recall involving certain FreeStyle Libre 3 sensors that could produce falsely high glucose readings. The FDA classified the action as a Class I recall in September 2024, suggesting that continued use of the devices could result in severe injury or death.

Abbott announced another correction in November 2025, affecting more than 3 million FreeStyle Libre 3 and Libre 3 Plus sensors that could provide falsely low readings. Following hundreds of reported injuries and fatalities, the FDA classified this action as a Class I recall as well in January 2026.

Since the recalls, a series of FreeStyle Libre lawsuits have been filed alleging inaccurate readings caused users to make improper treatment decisions, resulting in hypoglycemia, hyperglycemia, diabetic ketoacidosis (DKA) and other complications.

DKA is a potentially life-threatening condition that occurs when the body lacks enough insulin, causing dangerous levels of ketones to build up in the bloodstream.

FreeStyle Libre 3 Sensor Allegations

According to this recently filed complaint, Horn has type 2 diabetes and began using FreeStyle Libre 3 Plus sensors in mid-2024. He alleges the devices produced inaccurate glucose readings compared with fingerstick tests and sometimes failed to provide alerts.

The lawsuit notes that Abbott had received reports of 736 serious injuries and seven deaths worldwide potentially associated with affected sensors as of November 14, 2025, including 57 injuries in the United States.

In January 2026, the FDA issued Abbott Diabetes Care a warning letter identifying manufacturing and quality-control violations involving performance specifications, third-party manufacturing and final-product controls intended to ensure the sensors met glucose-accuracy requirements.

Horn alleges the problems extended beyond recalled sensors and argues the 2024 recall involving falsely high readings, followed by the 2025 recall involving falsely low readings, showed Abbott was already aware of broader manufacturing and quality-control problems.

He stopped using the system after learning about the alleged defects and recall. Horn maintains he relied on Abbott’s claims about sensor accuracy, real-time alerts and reduced need for fingersticks, and would not have purchased the devices had the problems been disclosed.

“The Defect caused real harm to real patients, including Plaintiff, yet Abbott chose to continue selling the defective Sensors rather than take prompt corrective action.”

— Gary Horn v. Abbott Laboratories et al.

The proposed nationwide class includes consumers who purchased FreeStyle CGM systems, Libre 3 or Libre 3 Plus sensors or related components and accessories. Horn raises allegations of fraudulent concealment, unjust enrichment, breach of express and implied warranties and violations of the Connecticut Unfair Trade Practices Act. He seeks damages, restitution and other relief.

Abbott FreeStyle Libre Lawsuits

While Horn’s complaint seeks compensation for consumers’ economic losses, Abbott also faces product liability lawsuits from individuals who claim inaccurate FreeStyle Libre readings caused serious injuries after they relied on faulty sensor data to make insulin dosing and other treatment decisions.

Individuals who suffered serious health problems after using a recalled FreeStyle Libre 3 or FreeStyle Libre 3 Plus continuous glucose monitor may be entitled to pursue financial compensation. Reported complications associated with inaccurate glucose readings include:

• Wrongful death
• Severe hypoglycemia
• Seizures
• Confusion
• Loss of consciousness
• Diabetic ketoacidosis (DKA)
• Other acute metabolic emergencies and hospitalizations

FreeStyle Libre 3 lawyers are reviewing cases for individuals and families nationwide who suffered serious injuries after relying on inaccurate glucose readings. Free consultations are available to determine whether you may be eligible to pursue a claim, with no legal fees unless a recovery is obtained.

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