China NMPA Product Recall - Single-balloon electronic small bowel endoscopy system

On October 26, 2021, Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its single-balloon electronic enteroendoscopy system. This action was prompted by a significant discrepancy identified in the documentation for specific components: the disposable endoscope outer cannulas, models ST-SB1 and ST-CB1. The issue concerned an inconsistency between the production address listed on the medical device registration certificate and the address displayed on the foreign language labels for these critical parts. The recall, overseen by the National Medical Products Administration (NMPA) and reported by the Shanghai Municipal Drug Administration, impacts products registered under certificate number 国械注进20153063035. A Class III recall typically indicates that the product defect is unlikely to cause adverse health consequences. While the document does not specify inspection dates, the recall notification itself was published on the aforementioned date. Olympus Trading (Shanghai) Co., Ltd. is responsible for addressing this labeling and documentation inaccuracy to ensure compliance with regulatory standards. Affected parties are directed to refer to the "Medical Device Recall Event Report Form" for comprehensive details regarding product models, specifications, and batch numbers involved in this corrective action.