China NMPA Product Recall - Electronic nasopharyngeal endoscope; electronic nasopharyngeal endoscope; video endotracheal intubation endoscope; fiber optic bronchoscope; ultrasonic fiber optic electronic bronchoscope; OES fiber optic bronchoscope; OES bronchial fiber optic endoscope; electronic bronchoscope (trade name: EVIS LUCERA); electronic bronchoscope (trade name: EVIS EXERA II); electronic bronchoscope; electronic bronchial endoscope; EVIS electronic bronchoscope; ultrasonic fiber optic electronic bronchoscope; ultrasonic fiber optic bronchoscope; electronic bronchoscope; bronchoscope (trade name: EVIS LUCERA); EVIS bronchial electronic endoscope; electronic bronchoscope (trade name: EVIS LUCERA); electronic bronchial endoscope; fiber optic bronchoscope

Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall of various electronic endoscope products, including electronic nasopharyngeal endoscopes, video tracheal intubation endoscopes, fiberoptic bronchoscopes, and ultrasonic fiberoptic electronic bronchoscopes. This recall, published on August 6, 2019, addresses a significant safety concern. The core issue arises when non-Olympus accessories are used with the affected devices, leading to excessive external force being applied to the bronchoscope forceps tubing. This can cause the biopsy port to loosen. While it has not been determined if this issue has resulted in patient infection or death, the company is taking proactive steps to mitigate potential risks to patient safety. The recall operates under China's medical device regulatory framework, with affected products holding registration certificates from authorities such as the Shanghai Food and Drug Administration and the National Medical Products Administration (NMPA). As a required action, Olympus Trading (Shanghai) Co., Ltd. is recalling all specified models, specifications, and batches of the affected endoscopes. Detailed information regarding the specific products involved can be found in the