The Food and Drug Administration (FDA) announced a “most serious type” of recall related to certain glucose monitor sensors. “The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it,” the FDA stated in a release. “In December, some models of FreeStyle Libre 3 and FreeStyle Libre 3 Plus were recalled due to the sensors providing incorrect low glucose readings,” FOX 13 Tampa Bay stated. “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,” the FDA continued. The FDA listed the following info about the recalled items: 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 Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and 3 Plus Sensors https://t.co/xXmk0ypcos pic.twitter.com/RU5RIi01T5 — US FDA MedWatch (@FDAMedWatch) February 4, 2026 FDA explained further: Abbott Diabetes Care is recalling certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors due to incorrect glucose readings that are lower than actual blood glucose levels. If undetected, these incorrect (lower than actual) glucose readings over an extended period may lead to wrong 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. As of January 7, 2026, Abbott has reported 860 serious injuries, and seven deaths associated with this issue. The FreeStyle Libre 3 and FreeStyle Libre 3 Plus Continuous Glucose Monitoring Systems are real time continuous glucose monitoring (CGM) devices with alarm capability indicated for the management of diabetes in persons age four and older. These devices are intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The Systems also detect trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The Systems are also intended to autonomously communicate with digitally connected devices. The Systems can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The Food and Drug Administration (FDA) has now identified the previous recall of certain FreeStyle Libre glucose monitor sensors as “most serious" and is warning that using the recalled device may cause serious injury or death if you continue to use it. https://t.co/9vADC3fxAl — FOX 4 NEWS (@FOX4) February 5, 2026 According to FOX 13 Tampa Bay, Abbott released the following statement regarding the updated recall: Abbott initiated a medical device correction on Nov. 24, 2025 for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the U.S. after internal testing determined that some of these sensors may provide incorrect low glucose readings. We immediately contacted customers to make them aware and provide support. Abbott has identified and resolved the cause of the issue, which relates to one production line among several that make Libre 3 and Libre 3 Plus sensors. The company continues to produce Libre 3 and Libre 3 Plus sensors to fulfill replacement and new orders and does not expect significant supply disruptions. More from FOX 13 Tampa Bay: The FDA says patients can determine if their current or unused sensor(s) are affected by visiting www.freestylecheck.com and selecting “CONFIRM SENSOR SERIAL NUMBER.” The serial number for the FreeStyle Libre 3 sensor or a FreeStyle Libre 3 Plus sensor can be found in the app or reader and also on the label on the bottom of the sensor applicator or carton. Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor(s). Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abbott Diabetes Care at 1-833-815-4273 or www.freestyle.abbott/us-en/support/contact-us.html Read the full FDA announcement HERE.