China NMPA Product Recall - Arm-type fully automatic electronic blood pressure monitor, model RAK288

Shenzhen Ruiankang Technology Co., Ltd. has initiated a voluntary recall of its arm-type fully automatic electronic blood pressure monitors. This action, announced by the National Medical Products Administration (NMPA) on July 6, 2022, and publicized by the Guangdong Provincial Drug Administration, concerns model RAK288, specifically batch number 28822021803867. The primary reason for the recall is that the product was found to be non-compliant with established standards during a routine random inspection. While the specific details of the non-compliance are not disclosed, the company is proactively addressing the issue. Under the regulatory framework of the NMPA, this has been classified as a Level III medical device recall, generally indicating a low likelihood of adverse health consequences. Shenzhen Ruiankang Technology Co., Ltd. is undertaking the required actions to remove the non-compliant devices from the market, with comprehensive details on affected products available in the "Medical Device Recall Event Report Form" to ensure public health and safety.