China NMPA Product Recall - Disposable ligation device

The National Medical Products Administration (NMPA) has announced a Class I voluntary recall initiated by Olympus Medical Systems Co., Ltd. concerning its single-use ligation devices. Published on December 2, 2025, the recall addresses critical safety concerns regarding the device's performance. Specifically, the disposable ligation devices (National Medical Device Registration Certificate No. 20172026749) have been identified with potential malfunctions, including the device not releasing or detaching as intended during surgical procedures. This significant recall, reported by Olympus Trading (Shanghai) Co., Ltd., categorizes the issue as Class I, indicating a high probability that the use of these defective devices could lead to serious adverse health consequences or even death. The regulatory framework overseeing this action is the NMPA, which is responsible for safeguarding public health in China through the oversight of medical products. As a required action, Olympus Medical Systems Co., Ltd. has taken the initiative to voluntarily withdraw the affected products from the market. Further detailed information regarding specific product models, specifications, and batch numbers is available in the "Medical Device Notification Form" and "Medical Device Recall Event Report Form." This proactive measure aims to mitigate potential risks to patients and healthcare professionals, ensuring compliance with NMPA's medical device safety regulations. The company's prompt action underscores its commitment to patient safety and product integrity.