China NMPA Product Recall - Flexor Ureteral Access S

Cook Incorporated, in collaboration with Cook (China) Medical Trading Co., Ltd., has initiated a voluntary Class III recall for its Flexor Ureteral Access Sheaths. This action, indexed as JGXX-2025-10052 and publicly reported by the National Medical Products Administration (NMPA) on May 8, 2025, addresses a manufacturing non-compliance related to the hydrophilic coating on the affected products. The issue concerns the coating's failure to meet established quality standards, which could potentially impact the device's performance and patient safety during medical procedures. Detailed information, including specific models, specifications, and batch numbers, is available in the accompanying "Medical Device Recall Event Report Form." It is important to note that the products involved in this recall were not imported into the NMPA's jurisdiction. This voluntary recall underscores the company's commitment to product quality and safety, overseen by regulatory bodies like the NMPA, even for products not distributed within their immediate geographic scope.