China NMPA Product Recall - Biopsy kit and accessories

Olympus Medical Systems Co., Ltd., through its subsidiary Olympus Trading (Shanghai) Co., Ltd., initiated a Class I voluntary recall for specific biopsy kits and accessories, as reported on February 25, 2025. This critical action was prompted by a significant product defect: the radiopaque marker tip of the device may detach and potentially fall into a patient's body during surgical procedures, posing a serious health risk.The recall is overseen by the National Medical Products Administration (NMPA) of China, with the affected products identified by National Medical Device Registration Certificate No. 20162020721. Although no specific inspection dates are listed in the recall notice, the severity of the issue necessitated an immediate Class I recall, indicating the highest level of recall due to the potential for severe adverse health consequences or even fatality.Consequently, Olympus Medical Systems Co., Ltd. is undertaking a comprehensive withdrawal of all identified biopsy kits and their related accessories from the market. Further details concerning the precise models, specifications, and batch numbers of the impacted devices are provided in the accompanying "Medical Device Recall Event Report Form," ensuring all hazardous products are promptly removed to safeguard patient well-being.