China NMPA Product Recall - Disposable high-frequency snare

On December 1, 2025, Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary recall of disposable high-frequency snagging devices manufactured by Olympus Medical Systems. This action was prompted by a significant quality concern: the potential for holes in the sterilization packaging of affected product batches. Such packaging defects could compromise the sterility of the medical devices, thereby posing a risk of infection to patients during use.The recall is classified as Level II by the National Medical Products Administration (NMPA), indicating a situation where the use of, or exposure to, the compromised product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The specific product subject to this recall holds National Medical Device Registration Certificate No. 20213010092. Detailed information regarding the models, specifications, and batch numbers involved is provided in the "Medical Device Recall Event Report Form" issued by Olympus Trading (Shanghai) Co., Ltd. All affected healthcare providers and distributors are advised to consult this official documentation for required actions and further guidance to ensure patient safety and regulatory compliance.