China NMPA Product Recall - Small medical oxygen concentrator

Foshan Meike Medical Technology Co., Ltd. initiated a voluntary Class III recall for its small medical oxygen concentrators. This action, published by the National Medical Products Administration (NMPA) on November 30, 2021, addresses a documentation error rather than a product malfunction. The main issue identified was an incorrectly printed fuse label within the instruction manuals accompanying the devices. Operating under the regulatory framework of the NMPA, with information disseminated via the Guangdong Provincial Drug Administration, the company is taking corrective measures. A Class III recall indicates that the product's use is unlikely to cause adverse health consequences. To resolve this, Foshan Meike Medical Technology Co., Ltd. is committed to shipping replacement manuals to all affected users. The specific models, specifications, and batches involved in this recall are detailed in the official Medical Device Recall Event Report Forms. This step ensures that users receive accurate and up-to-date operational information for their medical equipment.