China NMPA Product Recall - Passive instruments and accessories for endoscopic surgical instrument control systems

On December 30, 2021, Intuitive Surgical, Inc. initiated a voluntary Class II recall for specific passive instruments and accessories associated with its Intuitive Surgical® da Vinci® Xi Endoscopic Instrument Control Systems. This action was reported by the National Medical Products Administration (NMPA) due to the discovery of incorrect expiration dates printed on the sterile packaging labels, affecting both shipping cases and inner box labels for certain product models and batches. The issue specifically pertains to the accuracy of crucial sterility information displayed on the product packaging. Intuitive Surgical, Inc. proactively reported this discrepancy and is actively working to retrieve all affected items from the market. This recall underscores the company's dedication to maintaining product safety and adhering to regulatory standards set by the NMPA. Further details regarding the precise models, specifications, and batches involved are available in the accompanying "Medical Device Recall Event Report Form," ensuring that potential risks related to misleading expiration date information are mitigated and product integrity is upheld.