China NMPA Product Recall - Treatment Guidance System for Otolaryngology Surgery

The National Medical Products Administration (NMPA) has announced a voluntary Class III recall initiated by Medtronic Navigation, Inc., as reported by Medtronic (Shanghai) Management Co., Ltd. This action concerns the Otolaryngology Surgical Navigation System (National Medical Device Registration Certificate No. 20183010507). The primary issue identified for this recall is incorrect labeling on the product. While Medtronic Navigation, Inc. is the manufacturer, Medtronic (Shanghai) Management Co., Ltd. is responsible for reporting this incident within the NMPA's regulatory framework. A key detail of this recall is that the affected products were specifically not imported into China, ensuring that Chinese consumers and healthcare providers are not directly impacted within their national supply chain. Further details on specific models, specifications, and batches are available in the attached recall event report form. This proactive recall by Medtronic highlights the importance of accurate product information and adherence to global regulatory standards, underscoring NMPA's role in monitoring medical device safety.