China NMPA Product Recall - Disposable medical masks

Henan Xianghe Medical Supplies Co., Ltd. initiated a voluntary Level III recall of its disposable medical masks following a provincial medical device inspection. The recall, reported on November 10, 2020, by the National Medical Products Administration (NMPA) in China, stemmed from product non-compliance. The primary violations identified were related to the mask's physical integrity and performance: the tensile strength of the mask straps and the ventilation resistance (pressure difference) were found to be non-compliant with regulatory standards. The affected products belonged to batch number 20200406, Type A, Large Size, with 150,000 units produced and 90,000 units sold within China. As part of the required actions, the company's sales department immediately issued recall letters to customers. Although customers reported that the affected masks had already been used, no adverse reactions or events were observed. Furthermore, Henan Xianghe Medical Supplies Co., Ltd. inspected its finished product warehouse, destroying the remaining 60,000 non-compliant masks. The company also conducted a thorough analysis of materials and personnel to determine the root causes of the non-compliance, subsequently developing and implementing corrective and preventive measures to prevent similar issues in the future.