China NMPA Product Recall - Laparoscopic surgical instruments

Microline Surgical, Inc. has initiated a voluntary Class III global recall of its laparoscopic surgical instruments, specifically the ReNew repetitive manipulation heads (grasping and dissecting forceps). This action, reported to the National Medical Products Administration (NMPA) and documented on July 31, 2017, addresses a potential safety concern with the black heat-shrinkable insulation layer. The issue arises after high-temperature and high-pressure sterilization or re-sterilization, where the insulation layer exhibits a risk of cracking. Although Microline Surgical, Inc. has not received any reports of patient harm related to this defect, the recall was proactively undertaken to mitigate potential risks associated with the instrument's continued use. The affected products, registered under CFDA (Imported) 2014 No. 3220762, are utilized in laparoscopic surgery in conjunction with high-frequency generators for cutting and coagulation. As part of the required actions, Microline Surgical, Inc., through its agent Beijing Microline Medical Device Co., Ltd., issued recall notices to its domestic customers and confirmed receipt. All affected products have since been returned to the manufacturer for appropriate processing, ensuring their removal from the market. This recall underscores the company's commitment to product safety and compliance with regulatory standards.