China NMPA Product Recall - Introducer Sheath System with hydrophobic coating

The National Medical Products Administration (NMPA) has announced a Class III voluntary recall initiated by Contract Medical International, GmbH, concerning its Introducer Sheath System with hydrophobic coating (National Medical Device Registration Certificate No. 20182030226). This recall, reported by Baidu (Beijing) Medical Device Co., Ltd., stems from a potential issue involving incorrect labeling on the inner packaging of certain product batches. Identified under NMPA Index No. JGXX-2025-10107 and published on August 7, 2025, this action addresses a critical quality control concern impacting medical device accuracy. Despite the nature of labeling inaccuracies, it is explicitly stated that the affected products were not imported into China, thus mitigating direct risk to the Chinese market. The manufacturer is taking proactive measures by initiating this recall, indicating adherence to regulatory expectations for product safety and quality. Detailed information, including specific product specifications and batch numbers, is available in the accompanying "Medical Device Recall Event Report Form" attachment, which provides further context for stakeholders. This action underscores the NMPA's commitment to overseeing medical device safety and ensuring manufacturers address potential product deficiencies promptly.