Core Insights - The FDA issued a warning regarding malfunctioning blood glucose monitoring devices from Abbott, which may have contributed to seven deaths and hundreds of serious injuries [1][2] - Abbott has urged users to stop using the FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor devices immediately [1][5] Summary by Category FDA Warning - The FDA described the issue with Abbott's devices as a "potentially high-risk" problem, reporting 736 serious injuries and seven deaths associated with the malfunctioning devices as of November 14, 2025 [2][5] - The FDA and Abbott warned that the monitors may provide incorrect low glucose readings, which could lead to improper treatment decisions for diabetes patients [5][6] Abbott's Response - Abbott has identified and resolved the manufacturing issue affecting the sensors, noting that only one production line out of several is impacted, with approximately 3 million sensors affected [8] - The company will produce new devices to fulfill replacement and new orders, and does not expect significant supply disruptions [9] Consumer Guidance - Consumers can visit www.FreeStyleCheck.com to determine if their sensors are affected and obtain a replacement at no charge [9] - Abbott emphasized that no other Libre family sensors, readers, or apps are affected by this issue [11]
7 deaths linked to faulty blood glucose monitors as FDA issues safety warning