China NMPA Product Recall - Cleaning and sterilizing equipment

Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary Class II recall for specific models of its cleaning and sterilizing devices, namely S-8666 and S-8668. The recall, published on April 29, 2019, by the National Medical Products Administration (NMPA), was prompted by the manufacturer's discovery that the pump hose in certain units may deform during the cleaning process. This deformation could lead to a compromised cleaning effect, potentially impacting device hygiene and user safety. The company, operating under NMPA's regulatory framework (Medical Device Registration Certificate No. 20152573009), proactively identified this issue to ensure product safety and customer confidence, even though no complaints or adverse event reports related to this defect have been received. Maikewei (Shanghai) Medical Equipment Co., Ltd. is taking necessary action to address this performance concern. Customers are directed to the "Medical Device Recall Event Report Form" for detailed information regarding the specific product models, specifications, and batches involved in this recall.