The international FreeStyle Libre 3 recall warns diabetes patients of faulty glucose readings linked to severe injuries and deaths.
The U.S. Food and Drug Administration (FDA) has issued an international alert regarding the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, manufactured by Abbott Laboratories, after confirming seven deaths and more than seven hundred serious injuries linked to incorrect glucose readings. The official notice, published on December 2, 2025, affects millions of users of continuous glucose monitoring systems around the world and calls for immediate action to prevent further incidents.
The warning stems from numerous reports of adverse events tied to a manufacturing defect found in certain sensors. The FDA disclosed the problem using technical data provided by Abbott. The regulatory agency outlined the steps needed to verify the lot and serial number of potentially compromised devices. According to the official statement, most affected users live outside the United States, though incidents have also been detected domestically.
These sensors are part of the real-time glucose monitoring technology that thousands of people with diabetes rely on daily to track their blood sugar levels and adjust treatment. The identified defect affects system accuracy, which can result in improper insulin administration or counterproductive dietary changes, the FDA noted.
According to the FDA’s official site, the alert was prompted by a high number of reports involving severe injuries and deaths directly linked to defective FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors. The agency stated: “As of November 14, 2025, Abbott has reported 736 serious injuries and seven deaths associated with this issue.” The regulator added that the defect is specifically tied to inaccurate glucose readings that could lead to incorrect clinical decisions.
The health authority warned that individuals may experience symptoms of hypoglycemia or hyperglycemia that do not match the readings displayed by the device, requiring the use of alternative confirmation methods if there is any doubt. The agency also indicated that no other Libre-family monitors or associated mobile apps have shown similar issues, limiting the alert to specific identified lots.
The FDA identified the recall as affecting FreeStyle Libre 3 models (72081-01 and 72080-01) and FreeStyle Libre 3 Plus models (78768-01 and 78769-01). These products are associated with devices monitored under the following UDI-DI (unique device identifiers): 00357599818005, 00357599819002, 00357599844011, and 00357599843014. The regulator emphasized that the irregularity corresponds only to sensors manufactured on one Abbott production line during specific periods.
According to documents available on the FDA website and Abbott’s official platform, approximately three million sensors were identified as having potential measurement defects. These sensors were distributed globally. To determine whether a product is affected, users can enter the serial number at www.freestylecheck.com.
Based on the FDA’s breakdown, the defective sensors may produce falsely low glucose readings. This error exposes patients to risks associated with poor diabetes management. “If the incorrect reading goes undetected, it may lead to inappropriate treatment decisions for people with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions can pose health risks, including serious injury or death.”
The severity of the consequences led the agency and the manufacturer to issue specific instructions for verifying, stopping use of, and replacing compromised devices. Among the 736 severe events reported, cases include difficult-to-control hypoglycemia and hyperglycemia, as well as acute complications resulting from incorrect adjustments in diabetes therapy.
The FDA and Abbott have enabled the website www.freestylecheck.com, where users can check whether their sensor’s serial number belongs to the affected lot. The official notice instructs: “If your sensor is affected, stop using it immediately and request a free replacement through the available channels.”
The registration and verification process is quick, allowing patients to receive a free replacement. The FDA recommended using an alternative blood glucose meter until the correct sensor is received, and to stay in contact with their healthcare provider if symptoms do not match the monitor’s readings.
Abbott informed the FDA that “it has identified and resolved the issue in the affected production line, and manufacturing of replacement sensors is now underway.” The process includes free replacement of defective units and continuous monitoring of new cases by both the company and the agency.
Abbott has provided users with a dedicated support line and digital channels to speed up the process. Replacements extend to all countries where the affected lots were distributed. The manufacturer is working closely with international regulatory authorities to notify, collect, and replace the defective sensors.
Anyone using any FreeStyle Libre 3 or Libre 3 Plus sensor model should immediately check whether their device is part of the recall. If any irregularity is found, they should stop using the sensor, request a replacement, and use alternative monitoring systems. It is essential not to adjust medication without professional guidance and to record any discrepancies between symptoms and readings to report them through FDA or Abbott’s official channels.
The FDA reported that the rest of the FreeStyle Libre product line—including readers, mobile apps, and other versions such as FreeStyle Libre 2, FreeStyle Libre 14-Day, and Libre Pro—are not involved in the recall and can continue to be used normally.
According to the FDA, none of the seven deaths associated with defective sensors occurred in the United States. The 736 serious incidents were recorded both in the U.S. and abroad. The agency is currently overseeing the implementation of replacements and the simultaneous removal of potentially dangerous units alongside international health regulators.
These findings reinforce the importance of preventive corrective measures and highlight the critical role of post-market surveillance in medical devices. The global circulation of these sensors underscores the scale of the issue and the need for coordinated action to prevent new events.
The FDA regularly publishes all notices and ongoing investigations in its medical devices and recalls section (fda.gov). All instructions for verifying lots, reporting adverse events, and requesting assistance are centralized there.
The technical notice includes phone numbers, support links, and a reporting system for new incidents, allowing real-time monitoring of the recall’s global progress. According to the FDA: “Patient safety is the priority. We urge all users to consult official information and report any detected failures.”
Free replacement for affected sensors will continue until the recall process is complete, without interrupting user support. The FDA and Abbott will keep communication channels open for questions and incident reporting. Monitoring will remain active, and official information will be updated regularly. Transparency in managing this episode is expected to help prevent similar incidents with other medical devices in the near future.
