China NMPA Product Recall - Heart-Lung Transfer Heat Exchanger Unit

On January 5, 2026, the National Medical Products Administration (NMPA) issued a recall order concerning a voluntary recall initiated by Maquet Cardiopulmonary GmbH. This action addresses an issue with the company's Heater-Cooler Unit (HCU40 device), specifically involving inaccurate Japanese terminology. Maquet (Shanghai) Medical Equipment Co., Ltd. reported that the HCU40 device, when utilized in Japan, displayed incorrect temperature and pressure alarm prompts on its screen interface and within its instruction manual (IFU). This recall, identified under NMPA Index Number JGXX-2026-10004, highlights the regulatory body's role in overseeing medical device accuracy and safety. While the recall level is specified, further detailed information regarding affected models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form." It is important to note that the products implicated in this particular recall were not imported into China, limiting its direct impact on the Chinese market. The voluntary recall demonstrates the company's commitment to correcting product discrepancies and maintaining device operational integrity.