FreeStyle Libre 3 Lawsuit Overview

Libre 3 recall lawsuits allege that Abbott distributed millions of continuous glucose monitoring sensors affected by a manufacturing defect that caused incorrectly low glucose readings.

According to allegations raised in lawsuits, the defect originated from a specific production line and caused affected FreeStyle Libre 3 and Libre 3 Plus sensors to falsely indicate hypoglycemia even when a patient’s actual blood sugar levels were normal or elevated. 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.

The lawsuits further allege that Abbott marketed the devices as highly accurate and suitable for making treatment decisions without fingerstick confirmation, while failing to disclose well documented accuracy and reliability problems until the November 2025 recall.

By the time the recall was publicly disclosed, Abbott had reported hundreds of serious injuries and multiple deaths worldwide potentially associated with inaccurate Libre 3 sensor readings.

As a result, individuals and surviving family members are now filing Libre 3 recall lawsuits seeking compensation for medical emergencies, hospitalizations, long-term health complications, and wrongful deaths caused by reliance on inaccurate glucose readings

Who Can File a FreeStyle Libre 3 Lawsuit?

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.

All claims are handled on a contingency fee basis, meaning there are no upfront costs to hire a FreeStyle Libre 3 recall lawyer, and there are no attorney fees unless compensation is recovered.

2026 FreeStyle Libre 3 Lawsuit Updates

• January 6, 2025 Update: Following the recall, product liability lawyers across the country began investigating injury and wrongful death claims involving patients who relied on inaccurate Libre 3 glucose readings. Investigations are focusing on cases involving severe hypoglycemia, diabetic ketoacidosis, seizures, loss of consciousness, and other medical emergencies allegedly linked to the recalled sensors.
• November 24, 2025 Update: Abbott Diabetes Care issued a recall and urgent medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus sensors after identifying a manufacturing defect that could cause falsely low glucose readings. The company acknowledged hundreds of serious injuries and multiple deaths worldwide potentially associated with inaccurate sensor data, prompting an FDA Early Alert warning of a potentially high-risk device issue.

What Are the FreeStyle Libre 3 and Libre 3 Plus Sensors?

The FreeStyle Libre 3 and FreeStyle Libre 3 Plus are wearable continuous glucose monitoring systems used by people with diabetes to track blood sugar levels throughout the day and night. These devices are commonly used by individuals with Type 1 diabetes, insulin-dependent Type 2 diabetes, and others who require close, ongoing glucose monitoring to manage their condition safely.

Each system uses a small disposable sensor worn on the back of the upper arm. The sensor contains a thin filament inserted just under the skin that measures glucose levels in interstitial fluid and transmits readings wirelessly to a compatible smartphone or reader. Glucose values are updated every minute and are used to guide insulin dosing, carbohydrate intake, activity levels, and responses to high or low blood sugar.

The Libre 3 and Libre 3 Plus are marketed as allowing users to make treatment decisions without routine fingerstick testing, meaning many patients rely on these sensors as their primary source of glucose data. For people with hypoglycemia unawareness, children, older adults, and those at higher risk of blood sugar swings, accurate readings are essential for avoiding medical emergencies.

When glucose data is incorrect, users may take insulin they do not need or delay treatment they do need, increasing the risk of severe hypoglycemia, diabetic ketoacidosis, seizures, loss of consciousness, and other serious complications. These risks are central to concerns raised in the FreeStyle Libre 3 recall, which involves reports that certain sensors produced inaccurate low glucose readings.

FreeStyle Libre 3 Recall

In late November 2025, Abbott Diabetes Care issued an urgent medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring (CGM) sensors after internal testing found that some units may provide incorrect low glucose readings that could lead patients to make dangerous treatment decisions.

In affected units, the sensor may generate inaccurate low readings over extended periods, potentially causing a patient to misinterpret their glucose and adjust treatment in a way that could worsen blood sugar control or trigger an acute metabolic crisis.

The FDA characterized the problem as a “potentially high-risk” issue, warning that undetected incorrect low readings could lead to treatment decisions—such as delaying necessary insulin or taking unnecessary carbohydrates—that may pose serious health risks, including injury or death.

Which FreeStyle Models Were Recalled?

The recall affects approximately 3 million FreeStyle Libre 3 and Libre 3 Plus sensors distributed in the United States from a single production line, roughly half of which Abbott estimates have already been used or expired. The specific models included in the recall are:

• FreeStyle Libre 3 Sensors (Model Numbers 72081-01 and 72080-01)
• FreeStyle Libre 3 Plus Sensors (Model Numbers 78768-01 and 78769-01)

The recall does not apply to the FreeStyle Libre 3 reader device, mobile apps, or older Libre models such as Libre 2, Libre 2 Plus, Libre 14-day, or Libre Pro sensors.

Injuries and Deaths Linked to Recalled Libre 3 Devices

According to Abbott’s press release and information submitted to federal regulators, the company has received reports of 736 serious adverse health events worldwide potentially associated with the sensor issue, including 57 in the United States.

Abbott and the U.S. Food and Drug Administration (FDA) have also acknowledged seven deaths globally that may be linked to inaccurate Libre 3 sensor readings. None of the reported deaths occurred in the United States.

Injury reports describe serious health consequences caused by incorrect glucose data, including:

• False “low glucose” readings that mislead patients about their actual blood sugar levels
• Erroneous alarms prompting inappropriate treatment adjustments
• Instances of delayed or skipped insulin dosing
• Excessive carbohydrate intake based on inaccurate sensor output
• Emergency situations requiring medical evaluation and care.

What Users Are Being Told to Do

Abbott has instructed consumers with potentially impacted sensors to:

• Stop using affected sensors immediately if their device’s serial number matches one of the recalled lots.
• Check sensor status at www.FreeStyleCheck.com to confirm whether their device is part of the affected group.
• Request a free replacement sensor from Abbott if theirs is included in the recall.
• Use a traditional blood glucose meter or the built-in meter in the Libre 3 reader for treatment decisions if sensor readings do not match symptoms or expectations.

Injuries From Faulty FreeStyle Libre 3 Readings

Continuous glucose monitors play a critical role in diabetes management by guiding insulin dosing, carbohydrate intake, and emergency decisions. When a CGM provides inaccurate readings, especially falsely low values, individuals may unknowingly make treatment choices that place them at serious risk, including:

• Diabetic ketoacidosis (DKA): DKA is a life-threatening condition that occurs when the body lacks sufficient insulin and begins breaking down fat for energy, causing a dangerous buildup of ketones in the blood. False low readings may lead patients to delay or skip insulin doses, allowing blood sugar levels to rise unchecked and triggering DKA.

• Severe hypoglycemia or hyperglycemia: Incorrect readings can cause patients to take insulin they do not need or fail to take insulin when it is required. Severe hypoglycemia can result in shaking, confusion, seizures, or loss of consciousness, while prolonged hyperglycemia can cause dehydration, metabolic imbalance, and emergency medical crises.

• Heart complications, stroke, or organ damage: Extreme blood sugar fluctuations place significant stress on the cardiovascular system and vital organs. Acute episodes or repeated glucose instability may increase the risk of cardiac events, stroke, kidney injury, or other organ damage, particularly in vulnerable patients.

• Loss of consciousness or coma: Dangerously low or high blood sugar levels can impair brain function, leading to fainting, coma, or other neurological emergencies that require immediate medical intervention.

• Death, in extreme cases: In the most severe situations, untreated hypoglycemia, diabetic ketoacidosis, or related metabolic emergencies can be fatal, particularly if inaccurate sensor readings delay recognition and treatment.

Individuals who experienced medical emergencies, hospitalizations, or sudden worsening of their condition while relying on affected FreeStyle Libre 3 sensors may have grounds to pursue a product liability claim based on the reported safety risks associated with incorrect glucose readings.

History of Problems With Libre 3 Devices

Lawsuits involving the FreeStyle Libre 3 recall allege that Abbott was on notice of serious accuracy and manufacturing problems well before the November 2025 safety action, pointing to prior recalls, internal findings, and delayed public disclosure.

2024 Libre 3 High-Reading Defect Recall

According to lawsuits, Abbott had already experienced significant accuracy issues involving its FreeStyle continuous glucose monitoring systems before the Libre 3 low-reading recall.

In July 2024, Abbott initiated a FreeStyle Libre 3 sensors recall due to the devices recording incorrectly high glucose readings. The U.S. Food and Drug Administration later classified that action as a Class I recall, the agency’s most serious designation, reserved for devices that pose a reasonable probability of causing serious injury or death.

FDA officials warned that the issue may cause serious adverse health consequences, including severe low blood sugar (hypoglycemia) which can cause central nervous system problems, loss of consciousness, seizures, coma, permanent brain damage, and death.

The lawsuits allege that Abbott identified the Libre 3 defect through internal testing and post-market surveillance before issuing the November 2025 recall, yet continued manufacturing and distributing affected sensors without timely warnings to patients or healthcare providers.

Plaintiffs argue that the combination of a prior Class I recall, internal knowledge of accuracy failures, and delayed public disclosure demonstrates a pattern of quality control and safety oversight problems affecting Libre 3 devices, setting the stage for the product liability allegations now being raised.

2023 FreeStyle Libre Glucose Monitor Fire Hazard Recall

While unrelated to accuracy failures, in April 2023, Abbott Laboratories announced a Class I recall affecting more than 4.2 million FreeStyle Libre glucose monitoring systems after reports that the devices’ lithium-ion batteries could overheat, spark, or catch fire.

According to the FDA, Abbott received at least 206 reports of battery overheating, including seven fires and one reported injury, prompting regulators to warn that the devices posed a serious risk of injury or death.

The recall impacted multiple models, including the FreeStyle Libre, Libre 14 Day, and Libre 2 Flash systems. FDA officials warned that overheating could not only cause burns or fire-related injuries, but also prevent patients from using the device during a critical diabetes treatment moment.

Allegations Raised in FreeStyle Libre 3 Lawsuits

Recent Libre 3 recall lawsuits raise a series of product liability and consumer safety allegations, including claims that Abbott:

• Manufactured defective glucose sensors on a specific production line that produced falsely low glucose readings
• Failed to ensure sensor accuracy and reliability, despite marketing the devices as suitable for making treatment decisions without fingerstick confirmation
• Concealed known manufacturing defects identified through internal testing and post-market surveillance
• Delayed issuing warnings or corrective actions after receiving reports of serious injuries and deaths linked to inaccurate readings
• Misrepresented the safety and accuracy of FreeStyle Libre 3 and Libre 3 Plus sensors in marketing and labeling
• Failed to promptly notify patients and healthcare providers already using affected sensors about the risks
• Continued distributing sensors that allegedly posed a risk of severe hypoglycemia, diabetic ketoacidosis, seizures, and other life-threatening medical emergencies

These allegations form the basis of injury claims seeking compensation for medical treatment, hospitalization, long-term health complications, and wrongful death allegedly caused by reliance on inaccurate glucose readings from recalled Libre 3 sensors.

FreeStyle Libre 3 Recall Lawsuit Examples

Libre 3 Recall Lawsuit

On January 1, 2026, Christopher Taylor and Krystal Chambers filed a complaint (PDF) against Abbott Diabetes Care Inc. and Abbott Laboratories in the U.S. District Court for the Northern District of California, alleging that FreeStyle Libre 3 and Libre 3 Plus continuous glucose monitoring sensors produced falsely low glucose readings that placed diabetic patients at serious risk.

The plaintiffs allege they relied on Abbott’s representations that the devices were highly accurate and safe for treatment decisions without fingerstick confirmation while using the sensors to manage their diabetes.

According to the complaint, the defective sensors were manufactured on a specific production line and the accuracy problem was identified through Abbott’s internal testing and post-market surveillance before the company issued a public recall in November 2025. The lawsuit alleges Abbott failed to promptly warn patients and healthcare providers, continued distributing affected sensors, and exposed users to dangers including severe hypoglycemia, diabetic ketoacidosis, seizures, loss of consciousness, and death.

How to Start a Libre 3 Recall Lawsuit

Individuals who relied on recalled FreeStyle Libre 3 or Libre 3 Plus sensors and later suffered serious medical complications may qualify to pursue a product liability lawsuit.

Attorneys are reviewing claims for individuals and families who experienced medical emergencies or worsening health conditions after relying on inaccurate glucose readings. Lawyers are currently investigating:

• Cases involving emergency medical treatment or hospitalization
• Severe hypoglycemia or hyperglycemia linked to incorrect sensor readings
• Diabetic ketoacidosis or other acute metabolic crises
• Seizures, loss of consciousness, or neurological emergencies
• Long-term health complications following improper glucose management
• Deaths potentially linked to inaccurate glucose monitoring

Libre 3 recall lawsuits are handled on a contingency fee basis, meaning there are no upfront costs and no legal fees unless compensation is obtained through settlement or trial.