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

On September 21, 2020, Shenzhen Belles Electronic Technology Co., Ltd. initiated a voluntary Class III recall of its arm-type electronic blood pressure monitors, specifically model BLS-2009A from batch 09A20200430. This recall, overseen by the National Medical Products Administration (NMPA) and the Guangdong Provincial Drug Administration, was prompted by critical performance deficiencies. The primary issues identified were that the product's repeatability and pressure sensor accuracy failed to meet the standards set by YY0670-2008 and the product’s own technical specifications. These inaccuracies directly impact the reliability and validity of blood pressure measurements, posing a potential risk to users relying on these devices for diagnostic reference. In response, Shenzhen Belles Electronic Technology Co., Ltd. committed to several corrective actions. The company is actively notifying its distributors and customers in writing, requesting the return of all affected units. Furthermore, they plan to conduct a thorough root cause analysis to understand why these non-conformities occurred and implement robust corrective measures to improve product quality and compliance moving forward.