China NMPA Product Recall - Disposable masks and caps

Henan Anbang Medical Supplies Co., Ltd. initiated a voluntary Level III recall for 40,000 units of its Disposable Masks/Caps, model EK type/three-layer, from batch number 181102. This action followed a national medical device supervision and sampling inspection, during which the Beijing Medical Device Inspection Institute identified that the ventilation resistance of these products did not comply with the established technical requirements. The recall was formally reported to the Provincial Food and Drug Administration Department on August 26, 2019, and publicly announced by the National Medical Products Administration (NMPA) on December 16, 2019. Although 40,000 units were sold, the company confirmed that the entire affected batch had already been utilized, resulting in a physical recall quantity of zero. In response to this non-compliance, Henan Anbang Medical Supplies Co., Ltd. committed to analyzing the root cause of the issue and developing robust corrective and preventive measures to prevent similar quality deviations in the future, adhering to regulatory expectations for medical device safety and efficacy.