China NMPA Product Recall - Fiberoptic biliary endoscopy

On August 31, 2020, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Olympus Trading (Shanghai) Co., Ltd. This recall pertains to the company's fiberoptic biliary endoscope, specifically model CHF-CB30S (Registration Certificate No.: 国食药监械（进）字2013第2221875号). The decision to recall was prompted by Olympus' internal post-market risk assessment, which identified unacceptable risks associated with the product. The document, referenced under NMPA Index No. JGXX-2020-10423, highlights Olympus' proactive measure to address these identified safety concerns. As a Class II recall, this action signifies that the product may cause temporary or reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Further detailed information, including specific models, specifications, and batch numbers, is available in the "Medical Device Recall Event Report Form" attachment mentioned in the NMPA's announcement. This recall underscores the importance of continuous post-market surveillance and manufacturers' responsibility under the NMPA regulatory framework to ensure product safety and quality.