China NMPA Product Recall - Sonic Jaw Cordless Ultrasonic Dissection System (Handheld Ultrasonic Soft Tissue Cutting and Hemostasis Device)

On August 29, 2023, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. announced a voluntary Class II recall initiated by its manufacturer, Covidien LLC. This recall impacts the Sonic Jaw Cordless Ultrasonic Dissection System. The core issue stems from the reusable generator's manufacturing process, specifically the use of uncured epoxy resin components. When subjected to the heat of sterilization, this uncured resin's viscosity can decrease, leading to critical operational failures such as loss of audio or power, rendering the device unable to function as intended. Such malfunctions pose a potential risk to operational efficacy and patient safety. Overseen by the National Medical Products Administration (NMPA) of China, the Class II designation signifies a situation where the use of or exposure to the defective product may lead to temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. Covidien LLC is undertaking this voluntary action to address the identified manufacturing defect, with specific details regarding affected models, specifications, and batches provided in the official "Medical Device Recall Form."