Did You Suffer an Injury or Lose a Loved One Due to a Glucose Monitor Sensor Malfunction?
Certain glucose monitor sensors have been subjected to a Class I recall by the FDA due to a production line issue that allegedly caused certain devices to display blood sugar measurements than patients’ actual levels. Glucose monitor recall lawsuits allege that inaccurate device readings led to serious medical complications or wrongful death. The recalled devices have already been linked to over 800 serious injuries and at least seven deaths.
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Glucose Monitor Recall Lawsuits
Certain Philips Respironics ventilators, BiPAP and CPAP machines were recalled by the FDA due to the potential for the sound abatement foam inside the machines to degrade and enter the devices’ air pathway, which could cause users to swallow or inhale toxic gases and particles.
Individuals living with diabetes depend on continuous glucose monitoring technology to maintain safe blood sugar levels throughout their daily routines. These sophisticated medical devices provide real-time information that helps patients make critical treatment decisions, from insulin administration to dietary choices. When these monitoring systems allegedly malfunction and provide inaccurate readings, the consequences can extend far beyond inconvenience; they may result in severe medical emergencies, hospitalizations, or even loss of life.
Issues involving certain recalled continuous glucose monitoring devices have prompted widespread concern among patients, healthcare providers, and regulatory authorities. If you are dealing with injuries allegedly caused by a recalled glucose monitor sensor, it is important to understand your options. Speaking with an attorney who has experience handling glucose monitor recall claims may help you determine whether you have grounds to pursue a lawsuit against the manufacturer.
About the Glucose Monitor Recall
In November 2025, Abbott Diabetes Care initiated an urgent medical device correction affecting approximately three million FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitoring sensors distributed across the U.S. The company issued notifications to distributors, healthcare facilities, and individual users regarding specific batches of their continuous glucose monitoring technology.
According to the manufacturer’s communications, internal quality testing identified a production line issue that allegedly caused certain devices to display blood sugar measurements lower than patients’ actual physiological levels. This type of error carries significant implications because patients and caregivers responding to apparent low blood sugar warnings might consume additional carbohydrates or delay insulin administration—actions that could paradoxically drive blood sugar to dangerous heights when the initial reading was inaccurate.
Injuries and Deaths Allegedly Linked to Recalled Glucose Monitor Sensors
The U.S. Food and Drug Administration subsequently classified this action as a Class I recall—the agency’s most serious designation. This classification indicates that the FDA believes using these particular devices may carry risks of significant harm or fatal outcomes. In its November 2025 press release, Abbott reported that the company had “identified and resolved the cause of the issue.” However, as of January 2026, Abbott had reported “860 serious injuries, and seven deaths associated with this issue.”
Glucose Monitor Sensors Affected By the Recall
The manufacturer’s urgent correction specifically identified two product lines within their continuous glucose monitoring portfolio. These small, disc-shaped devices attach to the back of the upper arm and continuously measure glucose levels through a tiny filament inserted just beneath the skin surface. The sensors wirelessly transmit readings to smartphone applications or dedicated reader devices, providing users with current glucose measurements and trend information.
According to the FDA, the glucose monitor sensors affected by the Class I recall include the following, manufactured by Abbott Diabetes Care:
- FreeStyle Libre 3 Sensor
- Model Numbers: 72081-01, 72080-01
- Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002
- FreeStyle Libre 3 Plus Sensor
- Model Numbers: 78768-01, 78769-01
- Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014
Why Are Glucose Monitor Recall Lawsuits Being Filed
Legal actions have emerged in response to allegations that Abbott Diabetes Care knew or should have known about potential device defects before they caused harm to users. Plaintiffs pursuing glucose monitor recall lawsuits may raise claims based on alleged manufacturing defects, design defects, or inadequate warnings about potential device failures. Some complaints may allege that the company failed to provide timely or sufficient notice to users about the potential risks associated with these devices, potentially allowing individuals to continue using allegedly defective sensors without awareness of the danger.
Glucose Monitor Recall Class Action Lawsuits
Class action complaints filed in federal court have alleged that purchasers paid premium prices for these medical devices based on representations about their accuracy and reliability. When devices allegedly fail to perform as promised, consumers may have grounds to seek compensation for the difference between what they paid and the actual value of the defective product.
Alleged Complications From Recalled Glucose Monitors
Beyond economic damages, individual glucose monitor lawsuits have been filed by patients or their families alleging that inaccurate device readings led to serious medical complications or wrongful death. These claims typically seek compensation for medical expenses, pain and suffering, lost income, and in fatal cases, the loss of companionship and support experienced by surviving family members.
One tragic case involved a California man who reportedly relied on his continuous glucose monitoring device while his son served as his primary caregiver. According to a wrongful death lawsuit filed by the man’s son, Davonte Ford, against Abbott, the device repeatedly displayed low blood sugar readings one morning, prompting the caregiver to administer fast-acting carbohydrates as medically instructed. When the readings allegedly remained low despite these interventions, additional sugary foods and beverages were provided.
Emergency responders who arrived later reportedly measured the patient’s actual blood sugar at more than triple the normal range—a dangerously elevated level rather than the low readings the device had displayed. The patient allegedly died the following day after suffering multiple cardiac arrests.
Who May Qualify for a Glucose Monitor Recall Lawsuit
Individuals who experienced medical complications allegedly related to inaccurate continuous glucose monitoring device readings may have grounds to pursue legal claims against the manufacturer. Qualification typically depends on several factors, including whether the person used one of the specifically identified device models during the relevant timeframe, whether they can demonstrate that their device provided inaccurate readings, and whether they suffered measurable harm as a result. Patients who required emergency medical treatment, hospitalization, or experienced serious health complications after responding to allegedly false low blood sugar alerts may be eligible to seek compensation through individual injury claims.
Family members of individuals who allegedly died as a result of complications related to glucose monitor device malfunction may be able to file wrongful death lawsuits. These claims typically must be brought by specific family members as defined by state law, often including surviving spouses, children, or parents. Wrongful death actions seek compensation for the losses experienced by survivors, including funeral and burial expenses, medical costs incurred before death, loss of the deceased person’s expected financial contributions, and the intangible loss of companionship, guidance, and emotional support. The legal standards and available damages in wrongful death claims vary by jurisdiction, making consultation with an attorney familiar with the laws of the relevant state essential.
What Does This Mean for Diabetes Patients?
If you currently use a continuous glucose monitoring device from any manufacturer, verify whether your specific device has been identified in any safety communications or recalls. For the Abbott FreeStyle Libre 3 and Libre 3 Plus sensors, visit the manufacturer’s verification website and enter your device serial number to determine if your sensor came from an affected production lot. If your device is identified as potentially impacted, discontinue use immediately and dispose of the sensor according to the manufacturer’s instructions. Contact your healthcare provider to discuss alternative monitoring methods and request replacement devices. Keep all packaging materials, device serial numbers, and documentation related to your device, as this information may be important if you later decide to pursue legal action.
If you experienced medical complications that you believe may be related to inaccurate glucose monitoring device readings, seek appropriate medical evaluation and treatment as your first priority. Document your experiences thoroughly, including dates of device use, specific readings displayed, symptoms experienced, medical treatments received, and any communications with the device manufacturer or healthcare providers. Preserve the device itself if possible, as it may serve as important evidence. Request copies of your medical records related to the incident, including emergency department visits, hospital admissions, laboratory results, and physician notes.
Product Lawsuits
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1. Fill Out the Form
Keep the recalled glucose monitor, packaging, serial numbers, receipts, app screenshots, medical records, and any FDA recall notices or communications related to the device.
2. FREE Claim Review
Seek medical attention for any injuries or diabetic complications related to inaccurate glucose readings, missed alerts, hypoglycemia, hyperglycemia, seizures, loss of consciousness, or other health emergencies.
3. Speak With Us
Speaking with us can help you better understand your legal options, determine whether your recalled glucose monitoring device may qualify for a Continuous Glucose Monitor Lawsuit. Our team works with lawyers who review claims nationally at no cost to consumers.
What should you do? If you suffered a medical emergency or a loved one died as a result of complications allegedly linked to a recalled glucose monitor device, you should contact a lawyer as soon as possible to discuss filing a Glucose Monitor lawsuit.
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If you or a loved one experienced serious complications or death allegedly related to inaccurate glucose monitoring device readings, call us today or fill out the form on this page to be connected with an attorney who can evaluate your claim and explain your legal options. An experienced product liability lawyer understands the medical complexities of diabetes management, the technical aspects of continuous glucose monitoring technology, and the legal standards applicable to product liability claims, and can help you understand whether you may be entitled to compensation for the harm you have allegedly suffered.
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