China NMPA Product Recall - Laparoscopic cutting stapler and disposable stapler cartridge

On June 10, 2019, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its laparoscopic cutting stapler and disposable staple cartridge. This action followed the discovery of a manufacturing defect: a risk of missing connecting bolts within the devices. These bolts are crucial for maintaining the precise alignment of the instrument jaws, and their absence could lead to improper staple formation during surgical procedures. The affected products, registered under Shanghai Food and Drug Administration Medical Device Registration Certificate No.: 20153660082, pose a potential risk to patient safety. The recall, reported to the National Medical Products Administration (NMPA), aims to address this critical issue. Covidien is providing detailed information on the specific models, specifications, and batches involved through a "Medical Device Recall Event Report Form" to facilitate the efficient retrieval of affected units. This proactive measure reflects the company's commitment to ensuring the safety and reliability of its medical devices.