China NMPA Product Recall - Infrared forehead thermometer

Hunan Yinghe Kangyuan Biotechnology Co., Ltd. initiated a voluntary Class III recall of its infrared forehead thermometers, as announced by the National Medical Products Administration (NMPA) on November 19, 2021. This action followed non-compliance issues discovered during random inspections. The primary violations included the thermometers' failure to meet specified standards for temperature measurement range in human body mode, where they measured 32℃-42.5℃ instead of the required 32℃-43℃. Additionally, the automatic shutdown time was found to be 15 seconds, which did not align with established requirements. The recall affects 9900 units across several batch numbers, including 20200927, 20201207, 20201228, 20210113, 20210120, and 20210130. The regulatory framework for this recall is overseen by the NMPA, supported by the Hunan Provincial Drug Administration. As required actions, the company must issue recall notices to all domestic customers and ensure all recalled products are returned for processing, debugging, and calibration to rectify the identified non-conformities.