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

Shenzhen Ruiankang Technology Co., Ltd. initiated a voluntary Class III recall on May 19, 2022, for two of its medical devices: the arm-type fully automatic electronic blood pressure monitor and the medical infrared forehead thermometer. This action was reported to the National Medical Products Administration (NMPA) via the Guangdong Provincial Drug Administration.

For the blood pressure monitors (Model RAK268), the recall stemmed from a critical manufacturing issue. During production, a supplier secretly replaced chip raw materials due to a shortage, leading to products exhibiting poor radiation emission. Of the 500 units produced in batch 268210407, 452 had been sold and were deemed unrecoverable. Consequently, 48 units were confiscated by the inspection bureau, and the company was fined 50,700 yuan.

Regarding the medical infrared forehead thermometers (Model RAK-FI03), the recall was due to non-compliance with medical device labeling regulations. Product labels did not meet requirements concerning the "marking of controllers and instruments" and "symbols." From batch FI0320060129169, 10 of 50 units produced were sold before the issue was identified. The Shenzhen Municipal Bureau of Inspection imposed a separate fine of 10,000 yuan for this violation. These actions underscore the NMPA's commitment to upholding medical device safety and regulatory standards.