China NMPA Product Recall - Ultrasonic High-Frequency Surgical Integrated System Ultrasonic Scalpel Head

On July 29, 2021, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its Ultrasonic High-Frequency Surgical Integrated System Ultrasonic Scalpel Head. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, followed a complaint received by Ethicon Endo-Surgery, LLC. An investigation revealed that a small number of internal plastic parts in a specific batch of the ultrasonic scalpel heads might be damaged. In rare cases, this defect could cause the device to fire continuously if the part becomes stuck behind the energy key. Although surgeons are expected to quickly detect this issue through sensory feedback during use, the company proceeded with the recall to address the potential risk. The affected product, registered under Certificate No.: 20193010160, involves specific models, specifications, and batches detailed in a Medical Device Recall Event Report Form. This proactive measure demonstrates the company's commitment to product safety and compliance within the established regulatory framework.