China NMPA Product Recall - Ureteral sheath

Jieruishi Co., Ltd., acting on information from Olympus Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall for its ureteral sheaths. Announced by the National Medical Products Administration (NMPA) on May 22, 2023, this action addresses a significant product defect. The core issue involves the breakage of ureteral sheath dilators at the tip, which has been reported both before product packaging was opened and during surgical use. This malfunction presents potential risks to patient safety and surgical efficacy. The affected products are identifiable by National Medical Device Registration No. 20162020704. As a proactive measure, Jieruishi Co., Ltd. is responsible for executing this recall to prevent further incidents. Comprehensive details concerning specific affected models, specifications, and batch numbers are available in the associated "Medical Device Recall Event Report Form." This regulatory oversight by the NMPA underscores the commitment to maintaining high standards for medical device safety and quality in the Chinese market.