Lawyer For Injuries Caused By Recalled FreeStyle Libre Glucose Monitors

Millions of recalled FreeStyle Libre devices may be linked to dangerous misreadings, fires, and fatal events.

Continuous glucose monitoring (CGM) systems have revolutionized diabetes care by helping patients manage their blood sugar levels in real time. However, when these devices fail, the consequences can be catastrophic. That’s what happened with Abbott Laboratories’ FreeStyle Libre glucose monitoring systems, devices that are now the subject of an FDA Class I recall and a formal warning letter over manufacturing and safety violations.

What Parker Waichman LLP Found

Our legal team is reviewing thousands of pages of FDA documentation, internal memos, and public complaints, and we’ve identified key findings:

• Abbott failed to ensure final accuracy testing before shipping CGMs.
• Faulty USB charging practices may cause serious fire hazards.
• FDA found insufficient controls to separate user vs. device error in glucose readings.
• Sensors have been tied to fatal and life-threatening medical events.
• Patients may be eligible for compensation even if they didn’t suffer burns or hospitalization, and economic and emotional damages are also compensable.

Abbott’s FreeStyle Libre Readers and sensors have been linked to dangerous malfunctions, including incorrect glucose readings, overheating, fires, and patient deaths. The FDA’s findings raise concerns about device reliability and safety compliance.

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. Call 1-800-YOUR-LAWYER (1-800-968-7529) now for a free case review.

What the FDA Found at Abbott’s Facility

In January 2026, the U.S. Food and Drug Administration issued a formal warning to Abbott following a detailed inspection of its FreeStyle Libre production facility in Alameda, California. The inspection, which occurred in October 2025, uncovered multiple regulatory violations, including:

• Failure to properly translate design specifications into manufacturing processes.
• Lack of required finished-device testing before shipping products.
• Use of unverified third-party manufacturers without adequate oversight.
• Improper statistical techniques for quality control and validation.
• Inadequate procedures for maintaining product safety throughout the device lifecycle.

These violations suggest that Abbott may have shipped defective or poorly tested devices to patients across the U.S. for several years.

FDA Recall: Devices May Overheat or Catch Fire

The FDA issued a Class I recall for over 4.2 million FreeStyle Libre CGM readers, including Libre, Libre 14-day, and Libre 2 models, due to fire risk from battery issues.

The issue centers around rechargeable lithium-ion batteries in the Readers, which may overheat, spark, or catch fire when not charged with the original Abbott-supplied USB cables and adapters. Abbott acknowledged at least 88 reported incidents, including 7 device-related fires and one reported injury.

Patients are urged to test their devices and stop using incompatible charging cables immediately. Abbott has launched a dedicated site, FreeStyleBattery.com, to help users determine whether their Reader requires replacement.

Glucose Sensor Errors May Lead to Dangerous Misreadings

In addition to fire risks, the FreeStyle Libre 3 and Libre 3 Plus sensors have prompted a separate FDA safety communication over false low-glucose readings. These inaccuracies can cause users to skip insulin doses or consume excessive sugar, potentially leading to:

• Severe hyperglycemia
• Emergency hospitalizations
• Ketoacidosis
• Loss of consciousness
• Long-term organ damage

At least seven deaths have been reported in association with FreeStyle Libre device issues.

Who May Be Eligible for a Lawsuit?

Individuals may qualify for a legal claim if they:

• Experienced hospitalization, injury, or death due to false glucose readings
• Suffered property damage or burns from overheating or fires
• Used FreeStyle Libre Readers or sensors involved in the recall
• Incurred financial losses due to defective CGM performance

These cases are often filed under product liability laws, which allow consumers to hold manufacturers accountable for:

• Defective design
• Inadequate manufacturing or testing procedures
• Failure to warn of foreseeable risks
• Negligent oversight of third-party manufacturing partners

Patients do not need to have reported their device problem to Abbott or the FDA to pursue legal action.

FAQs – Legal Claims Related to FreeStyle Libre Devices

What is the main issue with FreeStyle Libre CGMs?

There are two major concerns. First, Reader devices may overheat or catch fire if they are improperly charged. Second, Libre 3 and 3 Plus sensors may produce dangerously incorrect glucose readings. Both pose severe risks to user safety and can lead to hospitalization or death.

Do I have to return my FreeStyle Libre device to file a lawsuit?

No. While product returns help support recall efforts, you can pursue legal action even if the device was discarded or lost—especially if you experienced a health emergency or damage related to its use.

What kinds of compensation can I seek?

Potential compensation includes medical costs, hospitalization, lost income, emotional distress, pain and suffering, and, in tragic cases, wrongful death damages. In some cases, punitive damages may also be awarded to punish corporate misconduct.

How do I know if my injury was caused by the device?

If you or your loved one experienced blood sugar-related emergencies, injuries, or death while using a FreeStyle Libre system, especially if tied to a false reading or charging problem, you may be eligible. Our legal team can help you investigate and confirm.

Is there a cost to speak with an attorney?

No. Parker Waichman LLP offers free consultations, and we only get paid if we recover compensation for you.

Contact Parker Waichman LLP For a Free Case Review

Parker Waichman LLP is a nationally recognized product liability law firm currently investigating legal claims related to FreeStyle Libre injuries, deaths, and property damage. We have a long track record of standing up to large corporations and holding manufacturers accountable for safety failures.

If you or a loved one has been harmed by a FreeStyle Libre CGM device, you may be entitled to financial compensation. Don’t delay. Your time to file may be limited depending on your state’s laws.

Call 1-800-YOUR-LAWYER (1-800-968-7529) now for your free legal consultation. Let us help you pursue justice. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.