China NMPA Product Recall - Capacitive Reusable Patient Return Electrode

Megadyne Medical Products Inc., in conjunction with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., has initiated a voluntary Class II recall of its capacitive Reusable Patient Return Electrode (National Medical Device Registration Certificate No. 20232010220). The recall, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., became public on July 14, 2023, under National Medical Products Administration (NMPA) Index No. JGXX-2023-10122. The primary reason for this action is reports of accidental skin thermal injury associated with the product's use. This significant safety concern prompted the manufacturer to remove the affected devices from circulation. The regulatory framework governing this action is the National Medical Products Administration (NMPA) of China, which oversees medical device safety and recalls within the country. Detailed information regarding specific product models, specifications, and batch numbers is available in the 'Medical Device Recall Event Report Form' provided by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The required action is a comprehensive voluntary recall to mitigate potential risks to patients and ensure product safety in the market.