China NMPA Product Recall - Disposable medical masks (English version)

Shaoyang Qiankangyi Medical Device Co., Ltd. voluntarily initiated a Class III recall for 252,000 units of its disposable medical masks, specifically batch number 20200318. The National Medical Products Administration (NMPA) documented this recall on July 15, 2020. The recall was prompted by a significant issue: the product packaging labels did not comply with the stringent requirements outlined in the "Medical Device Instructions and Label Management Regulations." This regulatory framework ensures that medical devices provide accurate and complete information to users and healthcare professionals. The affected masks, intended for medical units and clinical personnel during non-invasive procedures to create a physical barrier against pathogens, were distributed and sold in regions across China, including Shanghai. As required actions, Shaoyang Qiankangyi Medical Device Co., Ltd. was mandated to immediately implement the Class III recall and to halt all further production and sales of any products carrying the non-compliant labeling. This measure underscores the importance of regulatory adherence in medical device manufacturing and distribution, safeguarding public health and ensuring product information integrity.