China NMPA Product Recall - Fiberoptic hysteroscopy with flexible hysteroscopy

Olympus Medical Corporation, in conjunction with Olympus Trading (Shanghai) Co., Ltd., has initiated a voluntary Class III recall of its flexible hysteroscope (model number 20172061609). The recall stems from a procedural lapse where necessary changes to the label and packaging insert for the MD-159 suction button component were not implemented as required. This oversight led to non-compliance with regulatory standards for medical device labeling. The National Medical Products Administration (NMPA) of China published details of this recall on July 4, 2023, indicating that the manufacturer reported the issue and is taking corrective action. The recall specifically targets affected product models, specifications, and batch numbers as detailed in the accompanying "Medical Device Recall Event Report Form." This action underscores the importance of stringent change control processes for medical device components and documentation to ensure patient safety and regulatory adherence within the medical device industry.