China NMPA Product Recall - Fiberoptic nasopharyngoscope, electronic cystoporosis and pyelonephroscope, electronic cystoporosis and pyelonephroscope, fiberoptic cystoporosis and pyelonephroscope

Olympus Medical Corporation, through its subsidiary Olympus Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall of several medical devices in response to updated reprocessing instructions on their product labels. This action, reported to the National Medical Products Administration (NMPA) on December 5, 2023, involves fiberoptic nasopharyngeal endoscopes, electronic cystoscopy and nephrolithotomy endoscopes, and fiberoptic cystoscopy and nephrolithotomy endoscopes. The specific affected products include models such as the Nasopharyngeal endoscope (Giant 20172227142), electronic cystoscopic and renal pyeloscope (National Medical Device Registration Certificate 20182062429, 2012 No. 3223931), and fiberoptic cystoscopic and renal pyeloscope (No. 2220726). The primary issue prompting this recall is a modification to the instructions for cleaning and sterilizing these devices, which is critical for patient safety and preventing cross-contamination. This recall ensures that healthcare providers are informed of the updated reprocessing protocols to maintain the safe and effective use of these medical instruments. Detailed model and batch information is available in the 'Medical Device Recall Event Report Form' attached to the NMPA notice.