China NMPA Product Recall - Medical surgical masks

Jinan Xinchi Medical Technology Co., Ltd. has initiated a voluntary Level III recall of its manufactured surgical masks (Registration Certificate No.: Lu Xie Zhu Zhun 20202140868), as publicly announced by the National Medical Products Administration (NMPA) on August 25, 2022. This action stems from issues identified during random inspections, specifically that the mask's pull strap did not meet established requirements. Operating under the regulatory framework of the NMPA, the company has acknowledged a quality non-conformity in its product line. The recall requires Jinan Xinchi Medical Technology Co., Ltd. to remove affected surgical masks from distribution, with specific models, specifications, and batches detailed in the accompanying "E-Recall Event Report Form." This proactive measure highlights the company's commitment to compliance and the NMPA's role in ensuring medical device integrity for public safety.