Abbott Diabetes Care, a major player in the global diabetes technology market, has issued an urgent recall for approximately three million of its FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitor sensors. The recall, announced in late November and highlighted by the Food and Drug Administration (FDA) in an Early Alert on December 6, 2025, comes after internal testing revealed that some of these devices may provide incorrect low glucose readings—an error with potentially dire consequences for people living with diabetes.
The affected sensors were produced on a single manufacturing line, according to Abbott’s own investigation. The company estimates that about half of the impacted devices—roughly 1.5 million—have already expired or been used. Still, with millions of units distributed across 17 countries, including the United States, United Kingdom, and France, the recall’s reach is wide and its implications serious.
Continuous glucose monitors (CGMs) like the FreeStyle Libre 3 series have become a cornerstone in diabetes management. By providing real-time glucose readings via a small sensor placed just under the skin, these devices allow users to make rapid, informed decisions about their food, physical activity, and medication. As the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) explains, "Seeing your blood glucose levels in real time can help you make more informed decisions about the food and beverages you consume, the physical activity you do, and the medicines you take."
But when the technology falters, the results can be tragic. Abbott’s internal testing determined that some sensors may provide incorrect low glucose readings. As the company stated in its initial announcement, "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 problem became clear as reports mounted. As of November 14, 2025, Abbott had received notice of 736 severe adverse events—classified as serious injuries—linked to the faulty sensors. The company and the FDA have also confirmed seven deaths potentially associated with the malfunction, all of which occurred outside the United States. Of the 736 reported injuries, 57 were within the U.S. alone. The rest were scattered across the other affected countries, underscoring the global impact of the recall.
For many, the news has been unsettling. The UK’s Express reported that the recall has sent shockwaves through the diabetes community, especially as the devices are widely used to help patients manage their glucose levels with minimal daily disruption. The recall affects users in the UK, France, the U.S., and 14 other countries, making it one of the most significant medical device recalls in recent memory.
Abbott has moved quickly to contain the fallout. Customers are being urged to visit FreeStyleCheck.com to determine whether their device is affected. If so, they should "immediately discontinue use and dispose of it," as both Abbott and the FDA have advised. The company is offering free replacements for faulty sensors, aiming to ensure that users are not left without a safe means of glucose monitoring. Importantly, Abbott has clarified that the FreeStyle Libre 3 readers and mobile apps are not impacted by this recall. Other sensors in the Abbott portfolio, such as the FreeStyle Libre 14 day, FreeStyle Libre 2, Libre 2 Plus, and Libre Pro, are also unaffected.
The FDA’s Early Alert, issued just over a week after Abbott’s own announcement, reflects the seriousness with which regulators are treating the issue. The agency’s alert is a special communication reserved for "potentially high-risk issues," and includes a detailed list of affected products with model numbers and unique device identifiers. The FDA stated on its website, "The FDA is aware that Abbott Diabetes Care has issued a letter to distributors, health care providers, and affected customers recommending certain glucose monitor sensors be removed from where they are used or sold."
For those unfamiliar with the devices, a continuous glucose monitor is more than just a convenience—it is a lifeline. Diabetes, a chronic disease affecting the body’s production and response to insulin, requires careful, constant monitoring of blood sugar. Incorrect readings can lead to dangerous treatment decisions. For example, a falsely low reading might prompt a patient to eat extra carbohydrates or skip an insulin dose, which could result in dangerously high blood sugar levels, while a missed low could lead to hypoglycemia and severe complications.
The recall specifically affects the following models, according to the FDA and Abbott:
- FreeStyle Libre 3 Sensor (Model Numbers: 72081-01, 72080-01; UDIs: 00357599818005, 00357599819002)
- FreeStyle Libre 3 Plus Sensor (Model Numbers: 78768-01, 78769-01; UDIs: 00357599844011, 00357599843014)
Abbott has emphasized that it continues to produce sensors and does not expect significant supply disruptions as a result of the recall. Still, for the millions who rely on these devices, the recall is a stark reminder of the delicate balance between medical innovation and patient safety. As technology becomes more entwined with chronic disease management, even a single manufacturing flaw can have ripple effects across continents.
Health authorities and diabetes organizations have responded with urgency, underscoring the importance of accurate glucose monitoring. The FDA, in particular, has provided extensive information about the recall and has urged healthcare providers to communicate with their patients about the risks and next steps.
For those affected, the immediate priority is clear: check your sensor, follow the recall instructions, and ensure your glucose readings are coming from a reliable source. As Abbott and regulators work to resolve the issue, the episode serves as a sobering lesson in the high stakes of medical device reliability—and the critical importance of vigilance, both from manufacturers and the millions who trust their lives to these technologies.
As the story continues to unfold, users are encouraged to consult the FDA’s website and Abbott’s dedicated recall portal for the most up-to-date information. In a landscape where technology and health are increasingly intertwined, transparency and swift action remain the best safeguards against future crises.
