China NMPA Product Recall - Medical protective masks

Henan Scorsese Technology Development Co., Ltd. initiated a voluntary Level III recall of its medical protective masks (Model: 3D Folding Type, Product Code: 052002004) after a random inspection by the Guangdong Provincial Drug Administration identified non-compliance with sealing performance technical requirements. This recall, reported to the National Medical Products Administration (NMPA) and the Henan Provincial Drug Administration on June 26, 2020, addresses a critical issue that could compromise the masks' effectiveness in filtering particulate matter and blocking contaminants in medical environments. The company confirmed that the entire affected batch of 960 units had already been used, resulting in a recall quantity of zero units. In response, Henan Scorsese Technology Development Co., Ltd. is analyzing the root cause of the sealing non-compliance and developing corrective and preventive measures to ensure all future products meet stringent quality and safety standards, preventing recurrence of similar issues.