China NMPA Product Recall - Medical protective masks

Hunan Jiuhong Medical Technology Co., Ltd. initiated a voluntary Class III recall of its medical protective masks (Model JH-006, Batch 20200405), announced on October 20, 2020. The primary regulatory violation was the production of Class II medical devices without obtaining the mandatory medical device registration certificate, a requirement under the National Medical Products Administration (NMPA) framework. A secondary issue identified was that the product packaging was prone to opening during transportation. The recall affects 3,578 units produced by August 13, 2020, with 813 units sold in China, primarily via JD.com. Required actions for the company include establishing a recall leadership team, notifying all affected buyers, and ensuring that all recalled products are counted and destroyed under the supervision of the medical device regulatory department. Additionally, the company must conduct a comprehensive self-inspection and implement necessary rectifications to prevent future non-compliance.