China NMPA Product Recall - Electronic bronchoscope (trade name: EVIS EXERA II)

On September 9, 2020, Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its electronic bronchoscope, specifically the EVIS EXERA II model (Registration Certificate No.: CFDA (Imported) 2012 No. 3221125). This action was taken following an internal post-marketing risk assessment that identified a higher probability of patient infection associated with the BF-1T180 bronchoscope, a component within the EVIS EXERA II system, compared to other Olympus bronchoscope models. The recall, indexed as Shanghai Drug Administration Recall 2020-173, operates under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The required action involves the systematic removal of the affected devices from circulation to mitigate potential health risks. Detailed information regarding specific affected product models, specifications, and batches is accessible through the accompanying "Medical Device Recall Event Report Form" provided by the company.