China NMPA Product Recall - HL888UF Upper Arm Electronic Blood Pressure Monitor

Holtek Medical Electronics (Suzhou) Co., Ltd., also identified as HeTai Medical Electronics Suzhou Co., Ltd., initiated a voluntary Class III recall of its HL888UF Upper Arm Electronic Blood Pressure Monitor. This action, reported on March 15, 2019, followed national medical device spot checks that revealed non-compliance with critical product labeling requirements. Specifically, the monitors failed to meet clause 4.2.1n of the YY0670-2008 standard and clause 4.2.3i of the YZB/Su0559-2013 standard, both integral to medical device regulations in China. The recall, overseen by the National Medical Products Administration (NMPA), affected 432 units from batch number 101605121 that were sold in China, out of a total production batch of 3888 units. The affected product, registered under certificate code Su Medical Device Registration Certificate 20172201439, is designed for adult blood pressure and pulse measurement. In response, Holtek Medical Electronics implemented immediate corrective actions: all 432 sold units were fully recalled, with the non-compliant items undergoing prompt rework and rectification to comply with labeling standards. Additionally, all unsold finished products remaining at the factory are currently being reworked and rectified to ensure complete adherence to regulatory requirements before distribution.