China NMPA Product Recall - Disposable medical masks

Henan Chaoya Medical Device Co., Ltd. initiated a voluntary Level III recall for a specific batch of its disposable medical masks, reported to the National Medical Products Administration (NMPA) on November 4, 2020. The recall was prompted by an inspection report from the Shaanxi Provincial Medical Device Quality Supervision and Inspection Institute. This report, linked to products manufactured around March 29, 2020, identified a critical quality issue: the breaking strength of the connection point between the mask strap and the mask body was substandard. This non-compliance compromised the masks' structural integrity and functionality. A total of 20,890 affected pieces were produced, with 20,800 sold in China. To address this, Henan Chaoya Medical Device Co., Ltd. has taken immediate corrective actions under the NMPA's regulatory framework. These actions include issuing comprehensive recall notices and proactively contacting customers to facilitate the systematic return of the non-compliant masks. The company is actively managing the recall process to ensure the removal of all affected products from circulation, upholding product safety and quality standards.