China NMPA Product Recall - Piezoelectric atomizer

Hunan Anyu Medical Technology Co., Ltd. initiated a voluntary Class III recall for its piece-electric mesh nebulizers (model M202C, registration number 20212080050), as announced by the National Medical Products Administration (NMPA) on July 30, 2021. The recall was officially reported by the company on July 28, [Year]. The primary issue identified was non-compliant labeling; specifically, the product labels failed to indicate the essential level of protection against liquid ingress, which was specified as IP22. This omission constitutes a regulatory violation under the NMPA framework, as accurate and complete labeling is crucial for medical device safety and user information. The affected products included a specific production batch, 0304CNA0028, comprising five units. In response, Hunan Anyu Medical Technology Co., Ltd. implemented corrective actions. The company issued recall notices to all domestic customers who had received the affected nebulizers and ensured that all five units were successfully returned to the manufacturing facility. The required remedial action involves processing and relabeling these devices to correctly display the missing IP22 liquid ingress protection information, thereby rectifying the labeling deficiency and ensuring adherence to established regulatory standards for medical devices.