China NMPA Product Recall - Linear cutter and adjustable stapler (55/75mm) and selectable cartridge/reloads

Ethicon Endo-Surgery, LLC, with products distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary Class III recall on June 30, 2021. This action was taken due to a significant incompatibility issue identified between the linear cutter and its corresponding cartridge within the packaging of certain product models and batches. This packaging discrepancy could potentially affect the proper functionality and safety of the medical devices during their intended use. The main products implicated in this recall are the Linear Cutter 55/75mm and Selectable Cartridge/reloads, which are registered under certificate number 国械注进20152020243. The recall was reported to the National Medical Products Administration (NMPA), the relevant regulatory authority. A Class III recall signifies that the use of, or exposure to, the affected product is not likely to cause adverse health consequences, but corrective measures are still necessary. The required action involves the comprehensive retrieval of all identified affected products from the market to eliminate any risks associated with the noted incompatibility. Detailed information, including specific models, specifications, and batch numbers, is provided in the "Medical Device Recall Event Report Form" to facilitate the efficient management and return of the implicated devices, ensuring adherence to regulatory standards and patient safety.