Abbott Diabetes Care, one of the world’s leading manufacturers of glucose monitoring technology, has found itself at the center of a global health alert after reports surfaced linking some of its FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors to seven deaths and hundreds of serious injuries. The U.S. Food and Drug Administration (FDA), along with Abbott itself, has issued urgent warnings and initiated a sweeping recall impacting millions of devices worldwide.
The trouble began with internal testing at Abbott, which revealed that a batch of sensors—approximately three million units, all from a single production line—might provide incorrect low glucose readings. These sensors are designed to continuously monitor glucose levels in the fluid just beneath the skin, sending real-time data wirelessly to a user’s phone or reader. For people with diabetes, who rely on these readings to guide crucial treatment decisions, accuracy is not just important—it’s a matter of life and death.
According to the Associated Press, Abbott’s internal investigation found that some sensors could display glucose levels far below the user’s actual blood sugar. This faulty information can lead users to make dangerous choices: consuming excessive carbohydrates when it’s not needed or, perhaps more perilously, skipping or delaying vital insulin doses. Over time, such decisions can have dire consequences. As Abbott stated in its press release, “If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.”
The scope of the recall is staggering. The FDA, in its December 5, 2025 alert, specified that about three million sensors were affected in the U.S. alone, though Abbott estimates that roughly half of those have already expired or been used. The devices in question include FreeStyle Libre 3 sensors with model numbers 72080-01 (unique device identifiers 00357599818005 and 00357599819002) and FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 (identifiers 00357599844011 and 00357599843014). No other FreeStyle Libre products are impacted by the recall.
As of November 2025, Abbott had received reports of 736 severe adverse events potentially linked to the malfunctioning sensors, including 57 incidents in the United States. All seven deaths associated with the issue occurred outside the U.S., according to statements reported by NPR and NewsNation. The FDA has classified the problem as “potentially high-risk,” underscoring the seriousness of the threat posed by inaccurate glucose monitoring to people with diabetes.
For those unfamiliar, diabetes is a chronic condition that affects the body’s ability to produce or respond to insulin—a hormone that regulates blood sugar. Accurate glucose monitoring is the linchpin of diabetes management, guiding decisions on food, medication, and daily activity. When technology fails in this arena, the risks escalate quickly, from short-term complications like hypoglycemia or hyperglycemia to life-threatening emergencies.
Abbott, for its part, has moved swiftly to address the crisis. The company has notified all customers of the issue and set up a dedicated website, FreeStyleCheck.com, where users can check if their sensor is affected by entering their model number and unique device identifier. Abbott has pledged to replace any faulty sensors at no charge. In its statement, Abbott emphasized, “Customers who confirm their device is affected should immediately discontinue use and dispose of it.” The company also noted that it has identified and resolved the root cause of the problem in the affected production lot and does not anticipate significant supply disruptions for new or replacement orders.
For those currently using a potentially affected sensor, the advice is clear: stop using the device immediately. Both Abbott and the FDA recommend switching to a blood glucose meter or the built-in meter on a FreeStyle Libre 3 Reader for treatment decisions if sensor readings do not match symptoms. The FDA’s alert further cautions, “These decisions may pose serious health risks, including potential injury or death.”
It’s worth noting that while the vast majority of the reported deaths and injuries occurred outside the U.S., the impact has been felt globally. The recall has sent ripples through diabetes communities, patient advocacy groups, and healthcare providers, all of whom rely on accurate, reliable technology to keep millions of people healthy and safe.
In the broader context of medical device safety, this episode serves as a sobering reminder of the challenges manufacturers face in maintaining quality control—especially as devices become more complex and widely used. The affected FreeStyle Libre 3 and Libre 3 Plus sensors are among the most popular continuous glucose monitors on the market, lauded for their convenience and real-time data capabilities. But as this incident shows, even the most trusted brands are not immune to manufacturing flaws.
Regulators and industry observers have praised Abbott’s transparency and rapid response. According to the Associated Press, the company has already fixed the issue in its production process and continues to produce sensors while ensuring the safety of new and replacement devices. The FDA, meanwhile, has provided additional information on the recall and continues to monitor the situation closely.
For patients and families, the recall is more than just a technical hiccup—it’s a source of anxiety and disruption. Many people with diabetes depend on their glucose monitors for peace of mind and day-to-day safety. The sudden need to verify devices, dispose of faulty sensors, and adjust routines has added stress to an already challenging health journey.
Healthcare providers, too, are on high alert. They are advising patients to be vigilant, check their devices, and report any unusual symptoms or readings. The message from the medical community is one of caution but also reassurance: alternative monitoring methods are available, and help is on hand for those affected.
As the dust settles, questions remain about how a single production line could produce such a large number of faulty sensors and what steps will be taken to prevent similar incidents in the future. For now, Abbott’s recall and the FDA’s oversight offer a measure of protection, but the episode is likely to fuel ongoing debates about device regulation, quality assurance, and the balance between innovation and safety in the fast-evolving world of medical technology.
Ultimately, the Abbott glucose monitor recall stands as a stark illustration of the stakes involved in medical device manufacturing—and the importance of swift, transparent action when lives are on the line.
