ABBOTT FREESTYLE LIBRE 3 & 3 PLUS SENSORS LAWSUITS

Overview of Abbott FreeStyle Libre 3 & 3 Plus Sensors

Abbott FreeStyle Libre 3 & 3 Plus Sensors Lawsuits involve devices allegedly linked to inaccurate glucose readings, injuries, and deaths. Levy Konigsberg is investigating claims that Abbott FreeStyle Libre 3 and 3 Plus sensors produced inaccurate glucose readings that led to patient harm.

Abbott’s FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring (CGM) systems have recently come under scrutiny following a major recall linked to inaccurate glucose readings, serious injuries, and reported deaths.

The FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring systems are manufactured by Abbott Diabetes Care, a division of Abbott Laboratories, a global healthcare company specializing in medical devices, diagnostics, and pharmaceutical products. Abbott Diabetes Care develops glucose monitoring technologies designed to help individuals manage diabetes through real-time data and continuous tracking. These devices are widely used in both clinical and at-home settings and are intended to improve patient outcomes by reducing the need for traditional fingerstick testing and enabling more precise treatment decisions.

Abbott announced a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing revealed that some devices could produce inaccurately low glucose readings.

According to Abbott and regulatory findings, the issue was traced to a production-line manufacturing problem that caused some sensors to report glucose levels lower than actual blood sugar levels.

If you or a loved one was harmed, contact us today.

Research, Lawsuits, and Regulatory Action involving Abbott FreeStyle Libre 3 & 3 Plus Sensors

Recall and Safety Concerns

In November 2025, Abbott initiated a medical device correction and recall involving certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors after identifying a defect that could cause falsely low glucose readings.

The U.S. Food and Drug Administration (FDA) classified this as a Class I recall, the most serious type, meaning use of the device may cause serious injury or death.

Potential Health Risks

Because CGMs are often used to guide real-time treatment decisions, inaccurate readings can pose significant safety risks.

Falsely low glucose readings can lead patients to take incorrect actions, including:

• Consuming unnecessary sugar
• Skipping or delaying insulin doses
• Failing to recognize dangerously high blood sugar levels

These errors can result in serious complications, including hyperglycemia, hospitalization, or death.

Reported Injuries and Deaths

Regulators and public reports indicate that the recalled devices have been associated with:

• Hundreds of serious injuries
• At least 7 deaths worldwide

Abbott has also reported 736 adverse events globally.

Reports have described life-threatening medical events in which patients relied on inaccurate sensor readings. In one case, a caregiver followed repeated low-glucose alerts from a FreeStyle Libre 3 Plus device by giving sugar to a patient whose blood sugar was actually dangerously high; the patient later died after multiple cardiac events. Other users reported being sent to emergency rooms after receiving low glucose alerts that were later contradicted by standard blood tests, while some experienced fluctuating or inconsistent readings that did not match their symptoms. 

Legal and Regulatory Developments

The recall has triggered increased legal scrutiny and early litigation. Reports indicate that lawsuits have already been filed alleging that defective sensors contributed to severe injuries and wrongful deaths.

Potential legal claims may include:

• Defective manufacturing
• Failure to warn
• Negligence in quality control
• Delayed recall or inadequate safety communication

Legal Representation for Abbott FreeStyle Libre 3 & 3 Plus Sensors Lawsuits: Contact a Medical Device Attorney

If you or a loved one suffered harm after relying on a FreeStyle Libre CGM device, you may be eligible to pursue compensation.

An experienced product liability attorney can help determine:

• Whether a recalled device was involved
• The extent of injuries
• Available legal options 

Why Choose Levy Konigsberg?

• Experience: With decades of experience in complex litigation, our attorneys are well-equipped to handle product liability lawsuits.
• Results: We have recovered billions of dollars on behalf of our clients in mass tort and product liability cases.
• Personalized Attention: Each case is unique, and we provide personalized legal strategies tailored to our clients’ needs.

There are time limits for filing claims, so don’t wait to seek legal advice.