FreeStyle Libre Glucose Monitor Lawsuits

Millions of recalled FreeStyle Libre devices may be linked to dangerous misreadings, fires, and fatal events. Here’s what patients and families should understand and how to seek justice.

Continuous glucose monitors such as Abbott’s FreeStyle Libre systems have transformed diabetes care for millions of people. These devices are designed to provide real‑time glucose readings, helping users make critical decisions about insulin dosing, diet, activity, and overall health management. However, recent actions by the U.S. Food and Drug Administration (FDA) have raised serious concerns about the safety, accuracy, and quality controls associated with these widely used devices.

On January 23, 2026, the FDA issued a warning letter to Abbott Laboratories, identifying significant violations of manufacturing and quality system regulations at its Alameda, California, facility, where FreeStyle Libre CGMs are manufactured. The agency’s findings indicate that some manufacturing, testing, and monitoring processes may not ensure consistent device accuracy and reliability. This warning letter was made public on February 3, 2026, and followed earlier recall actions and safety alerts tied to sensor malfunctions and serious adverse events, including hospitalizations and at least seven reported deaths.

Separately, the FDA issued a public safety alert regarding certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors that are producing incorrect low-glucose readings. These false low readings can prompt dangerous treatment decisions, such as delaying insulin, skipping insulin doses, or consuming unnecessary carbohydrates, which in turn can lead to high blood sugar emergencies, hospitalizations, and other severe health consequences.

What Parker Waichman LLP Found

Parker Waichman LLP has reviewed the FDA warning letter, recall alerts, and adverse event reports related to FreeStyle Libre devices. Key findings include:

• The FDA alleges significant quality system breakdowns that could affect device accuracy and safety.
• Patients may have made critical medical decisions based on incorrect or unreliable glucose data.
• The warning letter follows a serious recall associated with hundreds of adverse events and multiple deaths.
• Abbott’s responses to the FDA were deemed insufficient, highlighting ongoing compliance concerns.
• Individuals harmed by these devices may have valid legal claims for compensation.

The combination of regulatory warnings, recalls, and reported patient harm has legal implications for individuals who have suffered injuries, emergencies, or financial losses due to inaccurate or malfunctioning FreeStyle Libre devices. Patients and families may have legal grounds to seek accountability and compensation through product liability claims based on defective design, manufacturing failures, inadequate warnings, or negligent quality controls.

This landing page provides a thorough explanation of the FDA’s concerns, the risks posed by device malfunctions, how incorrect glucose readings can harm users, what legal claims may be available to injured patients, and why it is important to seek legal consultation without delay.

Free Injury Claim Review

Parker Waichman LLP is actively investigating claims on behalf of patients and families who may have been harmed by FreeStyle Libre devices. Our firm is offering free legal consultations and pursuing compensation for those affected by inaccurate readings, CGM device fires, hospitalizations, or wrongful deaths. Contact us or call 800-968-7529 now for a free case review.

What You Need to Know About the FDA’s Warning Letter to Abbott

The FDA warning letter issued to Abbott on January 23, 2026, highlights four major categories of violations related to quality system regulation. These regulations are intended to ensure that medical devices are manufactured, tested, validated, and released in ways that protect patient safety and performance reliability.

1. Inadequate Control Over Design Transfer

The FDA found that Abbott failed to fully document and implement procedures that ensure a finished product matches its intended design specifications. When a device’s design criteria are not consistently translated into manufacturing specifications, there is no assurance that the final product will perform accurately.

The warning letter noted that Abbott did not clearly demonstrate whether critical performance testing was consistently conducted by Abbott or its contract manufacturers. Without clear documentation showing that performance requirements are integrated into manufacturing controls and final inspection criteria, users cannot be confident that the devices meet accuracy standards.

2. Insufficient Finished Device Acceptance Testing

Another FDA concern revolves around Abbott’s approach to finished device acceptance. The agency found that many FreeStyle Libre CGM devices were released without performance testing after final assembly, sterilization, programming, and packaging. Instead, testing was limited to unassembled components prior to assembly.

This is particularly troubling for devices that guide real‑time medical decisions. If a finished device has not been verified for accuracy after final assembly, the potential for unreliable readings increases, which can lead to inappropriate clinical decisions by patients or healthcare providers.

The FDA also noted that contract manufacturers responsible for final assembly were not furnished with adequate performance testing specifications, and they were not required to verify final device accuracy before release.

3. Lack of Statistically Valid Acceptance Criteria

Quality assurance in medical device manufacturing relies on statistically justified sampling plans and acceptance criteria. The FDA found that Abbott’s proposed sampling plans lacked objective statistical justification, such as confidence levels, power analyses, or risk‑based rationale. Without statistically valid criteria, there is no reliable framework to ensure that only safe and accurate devices are distributed.

The inspection showed that clinical performance monitoring did not separate manufacturing‑related variability from biological or behavioral variability inherent in patient use. This conflation undermines the ability to detect defective devices before they leave the factory.

4. Failure to Validate Devices for Real‑World Use

Even if a device meets accuracy criteria in pre‑market testing, manufacturers must demonstrate that the device continues to function as intended when produced in ongoing manufacturing. According to the FDA, Abbott lacked evidence supporting this ongoing validation under actual or simulated use conditions.

The FDA’s warning letter concludes that Abbott’s interim monitoring and proposed future testing plans did not provide objective evidence of consistent performance following release. As a result, the agency warned Abbott to address these deficiencies promptly or face regulatory actions, including seizures, injunctions, or monetary penalties.

FDA Public Alert: Incorrect Low Glucose Readings in FreeStyle Libre 3 Sensors

While the FDA warning letter focuses on manufacturing process concerns, a separate FDA alert specifically addresses the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, which have been linked to dangerous false low glucose readings. These readings can prompt incorrect treatment decisions with serious consequences.

According to Abbott’s own reporting to the FDA, more than 3 million sensors were affected by a manufacturing issue. As of November 14, the FDA noted:

• 736 serious injuries
• 7 deaths

associated with incorrect low glucose readings.

Why Incorrect Low Readings Are Dangerous

For people with diabetes, glucose readings inform immediate decisions such as:

• Whether to administer insulin
• Whether to consume carbohydrates
• Whether to seek medical attention
• How to respond during sleep or activity

When a sensor reports a falsely low reading, a patient might:

• Eat excessive carbohydrates unnecessarily.
• Delay or skip insulin doses
• Assume blood sugar is safe when it is actually high.

Each of these responses can lead to significant harm. Prolonged hyperglycemia increases the risk of diabetic ketoacidosis, vascular complications, hospitalizations, and long‑term organ damage.

Impact Across Age Groups

These sensors are approved for people aged four and up. This means children, teenagers, adults, and older adults may all be affected. Young children and adolescents are especially vulnerable because they may rely on caregivers to interpret device data and make treatment decisions.

Abbott’s Replacement Instructions

Abbott has advised users to confirm glucose readings with a blood glucose meter or the built‑in meter in the Libre reader when readings do not match expected symptoms. While replacements are offered at no charge for affected sensors, these corrective measures cannot undo injuries or losses already suffered.

Why These Device Issues Matter to Patients

Continuous glucose monitors are not optional devices—they are tools that guide life‑critical decisions for people managing diabetes. Faulty readings can:

• Prevent detection of true high blood sugar (hyperglycemia)
• Fail to alert users to dangerous low blood sugar (hypoglycemia)
• This leads to improper insulin administration.
• Causes delayed or inappropriate medical treatment.
• Result in emergency room visits, long‑term complications, or death.

When a device fails to perform as intended, the consequences can be immediate and severe. Even if the device is later replaced, the harm inflicted cannot always be reversed.

Legal Claims for Injured CGM Users

If you or a loved one experienced harm due to inaccurate or malfunctioning FreeStyle Libre devices, including hospitalization, emergency intervention, disability, or emotional trauma, you may have legal options. Product liability law allows injured individuals to seek compensation for losses caused by defective medical devices. Potential legal claims include:

Design Defect Claims

These claims assert that the device was inherently unsafe or flawed in design, posing unreasonable risks even when manufactured correctly.

Manufacturing Defect Claims

These claims focus on a particular device that deviated from its intended design due to errors in production or quality controls.

Failure to Warn Claims

These claims allege that the manufacturer did not adequately inform users of known risks. This includes inaccurate readings or fire hazards associated with device use.

Negligence Claims

Negligence claims argue that the manufacturer failed to exercise reasonable care. This may include designing, testing, manufacturing, or monitoring the device, resulting in preventable harm.

A successful claim can lead to compensation for:

• Medical expenses and ongoing treatment
• Hospital bills and emergency care
• Lost wages and diminished income capacity
• Pain and suffering and emotional distress
• Disability or long‑term care costs
• Wrongful death damages (when applicable)

FreeStyle Libre Lawsuit FAQs

Contact Parker Waichman LLP for a Free Case Review

If you or a loved one suffered harm, hospitalizations, or complications due to inaccurate FreeStyle Libre continuous glucose monitor readings, you may have legal options. Parker Waichman LLP represents individuals and families nationwide in medical device injury and product liability cases. Call (516) 466-6500 for a free, no‑obligation consultation to discuss your situation and learn whether you may qualify for compensation. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.