China NMPA Product Recall - Cleaning and sterilizing equipment

Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a Class II voluntary recall of certain cleaning and sterilizing devices (model 88-5) following the manufacturer's discovery of a critical product issue. The recall, publicly announced on January 19, 2020, through the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses devices produced before November 2012. The primary defect identified involves cracked solder joints within the chamber of the affected units. This structural compromise could lead to leakage, which in turn might cause significant inconvenience for users and disrupt or delay essential cleaning and sterilization processes. While these issues have the potential to impact operational efficiency, Maikewei (Shanghai) Medical Equipment Co., Ltd. has confirmed that no injury incidents related to this defect have been reported. Under the guidance of the NMPA, the company is taking proactive measures to manage this situation. The required action involves the comprehensive voluntary recall of all identified affected cleaning and disinfection equipment, as detailed in the "Medical Device Recall Event Report Form" (Registration Certificate No.: CFDA (Imported) 2012 No. 2570864). This action underscores the company's commitment to product safety and compliance with regulatory standards.