China NMPA Product Recall - Infrared forehead thermometer

Shenzhen Yineng Terminal Co., Ltd. initiated a voluntary Class III recall of its infrared forehead thermometers, specifically those from production batch number 20210401 with registration certificate number 粤械注准20202071951. This action, published on January 20, 2022, was necessitated by a critical non-compliance: the affected devices lacked essential manufacturer and supplier markings. This omission meant the products did not meet established regulatory standards, crucial for traceability and accountability within the medical device supply chain. The National Medical Products Administration (NMPA), through information disseminated by the Guangdong Provincial Drug Administration, oversaw this regulatory response. The required action involves the company actively recalling all non-compliant units from the market to correct this significant labeling deficiency. This measure underscores the importance of stringent adherence to medical device regulations, ensuring product safety and maintaining consumer confidence by guaranteeing proper identification and information for medical equipment available to the public.