China NMPA Product Recall - Medical surgical masks

The National Medical Products Administration (NMPA) published details on August 26, 2022, regarding a voluntary Class III recall initiated by Guangdong Bio-Con Medical Technology Co., Ltd., now known as Guangdong Mingli Medical Technology Co., Ltd. The recall specifically targets medical surgical masks from batch number 20220101. The primary issues identified involve significant quality deficiencies that fail to meet technical requirements for medical surgical masks as outlined in the YY0469-2011 standard. Key violations include insufficient tensile strength between the mask straps and the mask body, measured at less than 10 Newtons, and certain masks exhibiting excessive ventilation resistance, exceeding 49 Pa/cm². While specific inspection dates are not provided, the company proactively initiated this voluntary recall to address these non-conformities and ensure product safety. The action falls under the regulatory oversight of the NMPA, with further detailed information available in the company's "Medical Device Recall Event Report Form" for affected products.