China NMPA Product Recall - Tri-Staple™ 2.0 Reinforced Reload Single-use absorbable membrane stapler cartridge

The National Medical Products Administration (NMPA) announced on June 14, 2024, a Class II voluntary recall initiated by Covidien LLC, a manufacturer. The recall focuses on their single-use Tri-Staple™ 2.0 Reinforced Reload absorbable membrane anastomosis container, registered under National Medical Device Registration No. 20233010389. The recall was reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. The core issue driving this action is a manufacturing defect involving an incorrect setting of the staple cartridge latch workstation. This operational error leads to damage within the staple cartridge, compromising the product's quality and functionality for its intended use in endoscopic surgery. This voluntary recall, undertaken in accordance with NMPA guidelines, aims to address the identified product integrity concerns. Specific details regarding affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form," ensuring appropriate actions are taken to remove the faulty devices from circulation and uphold medical device safety standards.