China NMPA Product Recall - Disposable medical masks

Zhejiang Yilubo Biotechnology Co., Ltd. initiated a Class III voluntary recall for its disposable medical masks (Registration Certificate No.: Zhexiezhuzhun 20162640370). The recall, reported on November 5, 2018, and publicized by the National Medical Products Administration (NMPA) on December 3, 2018, was prompted by the product's failure to meet national quality standards. Specifically, independent testing commissioned by the State Drug Administration, conducted by the Henan Provincial Medical Device Testing Institute and re-tested by the Beijing Medical Device Testing Institute, confirmed that the bacterial filtration efficiency, particularly the fine band filtration efficiency, of batch 180402 did not comply with regulatory requirements. The affected product, identified as flat/176mm*97mm masks, involved 118 boxes distributed in China. In response, the company took several actions: formally notifying all distributors to cease sales of the non-compliant batch, recalling all existing products from the market, and committing to the complete destruction of the recalled batch under regulatory supervision. Furthermore, the company plans to strengthen warehouse management and enhance internal testing facilities to prevent recurrence and ensure future compliance.