FreeStyle Libre 3 Lawsuits Mount as FDA Issues Class I Glucose Monitor Recall

Manufacturer recalled certain FreeStyle Libre 3 sensors in November 2025 after internal testing found they could display falsely low blood sugar readings.

Following a growing number of adverse events related to certain Abbott FreeStyle Libre 3 and Libre 3 Plus continuous glucose monitors (CGM) producing dangerously inaccurate low blood sugar readings, federal health officials have issued a Class I recall.

The U.S. Food and Drug Administration (FDA) announced the recall of approximately 3 million FreeStyle Libre 3 CGM sensors on February 4, citing concerns that some units may not alert users to important changes in their glucose levels. A Class I recall is the FDA’s most serious designation, reserved for products that present a reasonable probability of causing serious injury or death.

Continuous glucose monitor sensors are small wearable devices, often worn on the upper arm, that continuously track blood sugar levels throughout the day. For people with diabetes, these readings are critical in helping them make decisions about insulin dosing, meals and daily activities to avoid dangerous spikes or drops in glucose.

Abbott first issued a recall of certain FreeStyle Libre 3 sensors on November 24, acknowledging that internal testing had identified an issue that may cause the devices to report falsely low blood sugar levels for extended periods, without triggering a warning to users.

Those inaccurate readings have sparked a growing number of Abbott Libre 3 lawsuits, with individuals alleging that misleading data led to unnecessary insulin use and serious health consequences, including severe hypoglycemia, confusion, loss of consciousness and other medical emergencies.

The FDA said Abbott has now received at least 860 reports of serious adverse events worldwide tied to the defective FreeStyle Libre 3 sensors, including dozens of cases in the United States, an increase from the 736 reports disclosed when the company first announced the recall in November. The agency indicated that at least seven deaths have been reported in connection with complications that may be linked to inaccurately low glucose readings.

Abbott estimates that approximately half of the affected sensors have already been used or have expired, though regulators emphasized that any remaining devices included in the recall should not be used.

Individuals are being instructed to immediately stop using affected sensors and safely dispose of them. Abbott has directed consumers to verify their sensor serial numbers through a dedicated recall website and to request replacement sensors at no cost.

The Class I recall does not impact FreeStyle Libre 3 readers, mobile apps or other Libre-branded glucose monitoring systems, including earlier Libre models.

Until replacement sensors are available, Abbott and the FDA recommend that patients rely on traditional finger-stick blood glucose meters or the built-in meter on compatible readers, particularly if sensor readings do not match symptoms or expected glucose levels.

Abbott FreeStyle Recalls 

This is at least the third major safety action involving FreeStyle Libre products in recent years. In July 2024, Abbott initiated a FreeStyle Libre 3 sensor recall after the devices were shown to record incorrectly high glucose readings. The FDA later classified that action as a Class I recall as well.

Prior to that recall, Abbott recalled about 4.2 million FreeStyle Libre glucose monitors in April 2023, following more than 200 reports of battery overheating incidents that were associated with fires and at least one documented burn injury.

U.S. customers can report adverse reactions, quality problems or questions to Abbott Diabetes Care at 1-833-815-4273 or https://www.freestyle.abbott/us-en/support/contact-us.html.

Other adverse reactions or quality problems may also be reported to the FDA’s Safety Information and Adverse Event Reporting Program, MedWatch.

FreeStyle Libre 3 Recall Lawsuits 

As the number of adverse events associated with the recalled glucose monitors continue to rise, attorneys across the country are investigating FreeStyle Libre 3 lawsuits on behalf of those who say they suffered serious injuries after relying on inaccurate sensor readings.

Individuals may be eligible to pursue a claim if they or a loved one used a recalled FreeStyle Libre 3 or Libre 3 Plus sensor and experienced any of the following severe health complications:

• Wrongful death
• Extreme hypoglycemia
• Seizures
• Confusion or altered mental status
• Loss of consciousness
• Diabetic ketoacidosis
• Other acute metabolic emergencies
• Hospitalization

Free case evaluations are available to help determine whether an Abbott FreeStyle Libre 3 lawsuit may be appropriate. Product liability attorneys can review the circumstances, explain potential legal options and assess whether a claim may be pursued.

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