China NMPA Product Recall - SpyScope DS II Access and Delivery Catheter for Disposable Biliary and Pancreatic Duct Endoscopy

Boston Scientific Corporation initiated a voluntary Class III recall of a specific batch of its SpyScope DS II Access and Delivery Catheter for single-use biliary and pancreatic duct endoscopic catheters. This recall, announced on October 29, 2025, and overseen by the National Medical Products Administration (NMPA), was prompted by an labeling error: an incorrect manufacturing address was displayed on product labels specifically in India.

The company emphasized that the issue does not impact product performance, and no harm or adverse events are anticipated from the affected devices. Boston Scientific has fully investigated and resolved the labeling discrepancy. The recall targets only the specific batch distributed in India, as detailed in the "Medical Device Recall Event Report Form." This action ensures compliance with regulatory standards for product labeling, addressing a clerical error rather than a product safety or efficacy concern. The recall underscores the importance of accurate regulatory information on medical device packaging.