China NMPA Product Recall - Closed stapler and disposable staple cartridge

On December 21, 2020, Covidien LLC, operating through Covidien Medical Devices International Trading (Shanghai) Co., Ltd., initiated a voluntary Class II recall for specific models and batches of its closed anastomosing devices and disposable attachment cartridges. This action was necessitated by the discovery of potentially damaged internal components within these medical devices. The primary concern is that such damage could prevent the anastomosis devices from activating correctly, thereby failing to effectively stop bleeding during surgical procedures. The recall is overseen by the National Medical Products Administration (NMPA), emphasizing its importance for patient safety. Details regarding the exact models, specifications, and batch numbers affected are provided in the "Medical Device Recall Event Report Form." This recall demonstrates Covidien LLC's commitment to product integrity and adherence to regulatory compliance.