China NMPA Product Recall - High-frequency surgical electrodes

Shanghai Hanjie Electronic Technology Co., Ltd. has initiated a voluntary Class III recall of its high-frequency surgical electrodes, specifically batch 181209401 of model CP1001. This action, publicly announced on April 20, 2020, followed a notification received by the company in December 2019 from the Market Supervision Administration. The notification indicated that the National Testing Institute had found the specified batch of electrodes to be substandard, necessitating their removal from the market. The recall falls under the regulatory framework of China's National Medical Products Administration (NMPA), with the announcement disseminated via the Shanghai Municipal Drug Administration. While the precise nature of the substandard condition is not detailed in this public notice, a Class III recall typically indicates that the product defect is unlikely to cause serious adverse health consequences. The company is required to manage the recall process, with comprehensive information on affected models, specifications, and batch numbers provided in a detailed "Medical Device Recall Report Form."