Federal health officials have issued a Class I recall for approximately 3 million Abbott FreeStyle Libre 3 and Libre 3 Plus continuous glucose monitors (CGM) after reports surfaced that some units were producing dangerously inaccurate low blood sugar readings. The U.S. Food and Drug Administration (FDA) classified the recall as Class I, its most serious designation, reserved for products that pose a reasonable probability of causing serious injury or death.
What happened
The recall follows growing concerns that certain Libre 3 sensors may fail to alert users to significant changes in their glucose levels. Continuous glucose monitors are wearable devices, often placed on the upper arm, that track blood sugar levels throughout the day. For individuals with diabetes, these devices provide critical data used to guide insulin dosing, diet, and daily activity. Accurate readings are essential to avoid dangerous spikes or drops in glucose, which can lead to severe complications or even death.
Abbott first issued a recall for some Libre 3 sensors in late 2025 after internal testing identified a problem that could cause sensors to display falsely low blood sugar readings for extended periods without alerting users. Since then, the number of adverse events linked to these devices has grown, prompting the FDA’s latest action.
Reported injuries and fatalities
The FDA reports that Abbott has received at least 860 worldwide reports of serious adverse events tied to the defective Libre 3 sensors, including dozens in the United States. These numbers have increased from 736 previously reported cases when the initial recall was announced. At least seven deaths have been reported in connection with complications that may be linked to inaccurately low glucose readings.
Patients and families have described severe medical emergencies caused by the devices. Reported incidents include extreme hypoglycemia, confusion, seizures, loss of consciousness, and other life-threatening metabolic events. Some individuals allege that inaccurate readings led them to administer unnecessary insulin, which exacerbated the danger.
Instructions for patients
Abbott and the FDA are urging anyone with affected sensors to stop using them immediately and dispose of them safely. The company has set up a dedicated recall website where consumers can verify sensor serial numbers and request replacement units at no cost.
The recall applies only to Libre 3 and Libre 3 Plus sensors. FreeStyle Libre 3 readers, mobile apps, and other Libre models are not affected. In the interim, patients are advised to rely on traditional finger-stick blood glucose meters or the built-in meter on compatible readers, especially if sensor readings do not align with symptoms or expected glucose levels.
A history of safety issues
This latest recall is at least the third major safety action involving Abbott’s FreeStyle Libre products in recent years. In July 2024, Abbott recalled Libre 3 sensors after some devices were found to record incorrectly high glucose readings, an action also classified as Class I by the FDA.
Earlier, in April 2023, Abbott recalled about 4.2 million FreeStyle Libre monitors due to reports of battery overheating. That recall was prompted by more than 200 incidents linked to fires and at least one documented burn injury. These repeated recalls have fueled concerns about the reliability of Abbott’s CGM technology and the company’s internal quality control processes.
Legal implications and lawsuits
The increasing number of adverse events has prompted legal investigations into potential product liability claims. Attorneys nationwide are reviewing FreeStyle Libre 3 lawsuits for individuals who experienced serious health complications after relying on inaccurate sensor readings.
Those who may be eligible to pursue claims include patients or family members of patients who used a recalled Libre 3 or Libre 3 Plus sensor and experienced one or more of the following outcomes:
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Wrongful death
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Extreme hypoglycemia
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Seizures
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Confusion or altered mental status
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Loss of consciousness
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Diabetic ketoacidosis
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Other acute metabolic emergencies
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Hospitalization
Product liability attorneys are offering free case evaluations to help determine whether an Abbott FreeStyle Libre 3 lawsuit is appropriate. Legal representatives can review the circumstances of each incident, explain potential options, and assess the viability of pursuing a claim.
How Abbott and the FDA are responding
Abbott has committed to replacing recalled sensors and providing guidance for patients to ensure their safety. The company is cooperating with the FDA to manage the recall and minimize risks to patients. The FDA emphasizes that even partially used or expired sensors included in the recall should not be used.
The agency has also reminded the public to report any adverse reactions, quality problems, or other concerns related to the FreeStyle Libre system. Reports can be submitted to Abbott Diabetes Care directly or to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. The FDA encourages consumers to be vigilant and to seek medical attention if they experience symptoms of dangerously low or high blood sugar.
Why accurate readings are critical
For people with diabetes, CGM sensors are more than convenience devices—they are essential tools for managing daily health. Inaccurate readings can have immediate and severe consequences, especially if a patient relies on them to make insulin dosing decisions. Even short periods of misreported blood sugar levels can lead to life-threatening complications such as hypoglycemia or diabetic ketoacidosis.
Healthcare professionals warn that faulty glucose monitoring devices can give a false sense of security, putting patients at risk. The FDA’s classification of the recall as Class I underscores the serious nature of the problem and the potential for injury or death if the sensors are not removed from use.
Looking ahead
Abbott faces scrutiny not only from regulators but also from patients, families, and the legal system. The company has pledged to work closely with health officials and to distribute replacement sensors as quickly as possible.
In the meantime, diabetic patients using FreeStyle Libre 3 or Libre 3 Plus sensors should exercise caution and monitor blood sugar with alternative methods. Public awareness of the recall is critical, given the serious risks involved.
The ongoing lawsuits, combined with repeated product recalls, may lead to further regulatory actions and increased oversight of continuous glucose monitoring technologies. Patients and families affected by the faulty sensors are encouraged to consult with healthcare professionals and to consider legal guidance if severe complications occurred.
Reporting and resources
Patients with questions or concerns about recalled FreeStyle Libre 3 sensors can contact Abbott Diabetes Care at 1-833-815-4273 or visit the company’s support website. Adverse events may also be reported to the FDA via the MedWatch program.
Legal assistance is available for those impacted. Attorneys are offering consultations to determine eligibility for claims related to wrongful death, hypoglycemia, diabetic emergencies, and other serious complications arising from inaccurate glucose readings.
Conclusion
The FDA’s Class I recall of Abbott FreeStyle Libre 3 and Libre 3 Plus sensors highlights the potential dangers of defective continuous glucose monitors. With millions of sensors affected and dozens of serious incidents reported, patients are being urged to stop using the devices immediately. The recall represents not only a public health alert but also an increasing wave of legal accountability for manufacturers of medical devices.
Diabetic patients and families must remain vigilant, monitor glucose levels through alternative means, and report any adverse events. As Abbott works to replace affected sensors, the case serves as a stark reminder of the importance of accurate medical devices in protecting patient safety.
James Jenkins is a celebrated Pulitzer Prize-winning author whose work has reshaped the way readers think about social justice and human rights in America. Raised in Atlanta, Georgia, James grew up in a community that instilled in him both resilience and a strong sense of responsibility toward others. After studying political science and creative writing at Howard University, he worked as a journalist covering civil rights issues before dedicating himself fully to fiction. His novels are known for their sharp, empathetic portraits of marginalized communities and for weaving personal stories with broader political realities. Jenkins’s breakout novel, Shadows of Freedom, won national acclaim for its unflinching look at systemic inequality, while his more recent works explore themes of identity, resilience, and the fight for dignity in the face of oppression. Beyond his novels, James is an active public speaker, lecturing at universities and participating in nonprofit initiatives that support literacy and community empowerment. He believes that storytelling is a way to preserve history and inspire change. When not writing, James enjoys jazz music, mentoring young writers, and traveling with his family to explore cultures and stories around the world.
