China NMPA Product Recall - Medical surgical mask (Model: SRS-SM-A)

Hunan Sanrui Biotechnology Co., Ltd. initiated a voluntary Level III recall for its medical surgical masks (Model SRS-SM-A, production batch number 20200903), as reported on May 20, 2021. This action was taken in cooperation with the Hunan Provincial Drug Administration and under the oversight of the National Medical Products Administration (NMPA). The primary reason for the recall was a critical quality defect: the tensile strength at the connection point between the mask strap and the mask body failed to meet required safety standards. This non-conformance could compromise the mask's intended function of providing basic protection for medical personnel and preventing the spread of bodily fluids and splashes. A total of 400,000 affected units were distributed exclusively within China. The required actions included the immediate implementation of the Level III recall, with the company's sales department mandated to promptly notify all customers about the recall information, ensuring the removal of the non-compliant products from circulation to maintain public health and safety standards.