China NMPA Product Recall - Electric laparoscopic linear cutting stapler and staple cartridge

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. and its manufacturer, Ethicon Endo-Surgery, LLC, initiated a voluntary Level III recall of a specific batch of Electric Laparoscopic Linear Cutting Staplers and Staple Cartridges. This action, reported on June 21, 2021, by the National Medical Products Administration (NMPA), was prompted by a potential discrepancy between the product's packaging specifications and its actual specifications. The primary concern identified was that this packaging error could necessitate device replacement during a procedure, potentially causing minor surgical delays. The recall specifically targets products with Registration Certificate No. 国械注进 (20163212453). The company's proactive recall aims to address and mitigate any risks associated with this packaging inconsistency, ensuring patient safety and product integrity under NMPA oversight. Detailed information regarding affected models and batch numbers is available in the accompanying Medical Device Recall Event Report Form.