China NMPA Product Recall - Ureteral Access Sheath

The National Medical Products Administration (NMPA) announced on October 17, 2024, a Class II voluntary recall of a ureteral access sheath manufactured by Gyrus ACMI, Inc. The recall was reported by Olympus Trading (Shanghai) Co., Ltd. The primary issue prompting this action is the identified problem of dilator tip breakage associated with the affected medical device, specifically bearing the index number 20162020704. Gyrus ACMI, Inc. has proactively initiated this voluntary removal of the product from the market to address the safety concern. This action is overseen by the NMPA to ensure public health and product quality standards are maintained within the medical device sector. Detailed information regarding specific models, specifications, and affected batch numbers is contained within the