China NMPA Product Recall - Capacitive neutral electrode

On January 19, 2024, the National Medical Products Administration (NMPA) published information regarding a voluntary Class I recall initiated by Megadyne Medical Products Inc. The concern was brought forward by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall specifically involves capacitive neutral electrodes (Registration Certificate No.: 20232010220). The primary issue identified is the potential for these electrodes to cause thermal injury to patients if they are not operated accurately according to the manufacturer's instructions for use. Megadyne Medical Products Inc. is voluntarily conducting this Class I recall, which indicates a high probability of serious adverse health consequences or death if the product is used. This significant regulatory action underscores the critical importance of strict adherence to operational guidelines for medical devices to ensure patient safety. Further details regarding the affected product models, specifications, and specific batch numbers are available in an attached "Medical Device Recall Event Report Form."