China NMPA Product Recall - Electronic upper gastrointestinal endoscopes and other products

The National Medical Products Administration (NMPA) has announced a voluntary Class III recall initiated by Olympus Medical Systems Co., Ltd., as reported by its subsidiary, Olympus Trading (Shanghai) Co., Ltd. This recall, published on November 13, 2024, addresses an issue where specific medical devices were incorrectly supplied to and subsequently used by customers. The primary concern stems from a distribution error rather than a product defect identified during an inspection; therefore, no inspection dates are noted. The affected products include the electronic upper gastrointestinal endoscope (Registration No. 20172061450), electronic biliary endoscope (Registration No. 20232060312), and an endoscopic imaging device (Registration No. 20192060469). Operating under the NMPA's regulatory framework, Olympus Medical Systems Co., Ltd. is required to undertake this proactive recall to rectify the distribution error. Further details regarding the specific models and batches involved are available in the 'Medical Device Recall Event Report Form' provided by Olympus Trading (Shanghai) Co., Ltd. This action ensures appropriate management and use of medical products in the market.