Glucose Monitor Devices Linked to Hundreds of Injuries and Multiple Fatalities

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for certain glucose monitor sensors manufactured by Abbott Diabetes Care, specifically the FreeStyle Libre 3 and FreeStyle Libre 3 Plus models. This recall is significant due to the fact that the recalled glucose monitor sensors have been linked to hundreds of injuries and at least seven reported fatalities. The FDA’s classification indicates that the use of these devices poses a serious risk of injury or death, prompting urgent action from both the manufacturer and healthcare providers.

Details of the FDA’s Glucose Monitor Sensor Recall

The FreeStyle Libre series of continuous glucose monitors (CGMs) has been widely used by individuals managing diabetes. These devices are designed to provide real-time glucose readings, allowing users to make informed decisions about their insulin intake and dietary choices. However, recent reports have raised concerns about the accuracy of readings from certain sensor lots, leading to the current FDA glucose monitor recall.

The primary issue identified with the affected sensors is the potential for inaccurate glucose readings, specifically readings that are lower than the actual blood glucose levels. This discrepancy can lead to dangerous treatment decisions, such as excessive carbohydrate consumption or inappropriate insulin dosing. If users or caregivers rely on these faulty readings, they may inadvertently put their health at risk.

Health Risks Potentially Linked to Faulty Glucose Monitor Sensors

The potential implications of using a malfunctioning glucose monitor sensor can be severe. Incorrectly low readings may cause individuals to underestimate their blood sugar levels, potentially leading to:

• Increased carbohydrate intake: Believing their blood sugar is under control, users may consume more carbohydrates than necessary, exacerbating their condition.
• Delayed or skipped insulin doses: Users may avoid taking insulin when needed, resulting in dangerously high blood sugar levels.
• Potential for severe health complications: Prolonged periods of mismanaged blood sugar can lead to serious health issues, including diabetic ketoacidosis (DKA), which can be life-threatening.

Reported Injuries and Fatalities

As of the latest updates, the FDA has linked the use of these recalled glucose monitor sensors to approximately 860 serious injuries and at least seven deaths worldwide. While the majority of these incidents occurred outside the United States, the potential for harm remains a critical concern for all diabetes patients using CGMs. The FDA has emphasized the importance of addressing this issue promptly to prevent further incidents.

One reported fatality involved a California man with Type 2 diabetes named Michael Ford. His son, Davonte, was his full-time caregiver, responsible for administering Michael’s medications and responding to blood sugar readings from Michael’s FreeStyle Libre 3 Plus sensor. One morning in November 2025, Michael’s CGM repeatedly issued low blood sugar alerts, and Davonte gave his dad fast-acting carbohydrates, just as doctors had instructed. When the readings remained low, Davonte gave his father sugary foods and beverages in an attempt to raise his blood sugar level.

When the paramedics arrived, their equipment measured Michael’s blood sugar at more than three times the normal level, far higher than the glucose monitor had indicated. Unfortunately, the discovery came too late. The next day, Michael suffered multiple cardiac arrests and died. Just seven days after Michael’s death, Abbott released a medical device correction warning affecting approximately three million FreeStyle Libre 3 and Libre 3 Plus sensors that the company said were at risk of producing false low readings and had already been linked to seven deaths and 736 serious injuries.

Glucose Monitor Sensors Affected By the FDA Recall

According to the FDA’s Class I recall announcement, issued on February 5, 2026, the glucose monitor sensors affected by the recall include the following devices and models:

• 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

Actions for Affected Users and Healthcare Providers

Diabetes patients using Abbott Diabetes Care’s FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensors are urged to take the following actions:

• Verify Sensor Status: Users should check if their sensors are part of the recall by visiting the official Abbott website or using the FreeStyleCheck tool.
• Discontinue Use: If a sensor is confirmed to be affected, users must stop using it immediately and dispose of it properly.
• Request a Replacement: Affected users can request a replacement sensor at no cost through the Abbott website.

Healthcare providers are advised to inform patients about the glucose monitor sensor recall and its potential implications, encourage patients to verify their sensor status and take appropriate action, and monitor patients closely for any signs of mismanaged blood sugar levels.

Navigating the Aftermath of the Glucose Monitor Recall

The recall of Abbott’s widely used glucose monitor sensors highlights the critical importance of device safety in diabetes management. As users navigate the implications of this recall, it is essential to remain informed and proactive in addressing any potential health risks. Individuals affected by the recall should take immediate action to verify their sensor status and seek replacements, while also considering their legal options if they have experienced harm. The ongoing collaboration between Abbott, healthcare providers, and regulatory agencies will be vital in ensuring the safety and well-being of those relying on these essential medical devices.