China NMPA Product Recall - Small medical oxygen concentrator

Foshan Meike Medical Technology Co., Ltd. has initiated a voluntary Class III recall of its small medical oxygen concentrators. This action, publicly announced on November 30, 2021, by the National Medical Products Administration (NMPA) and published through the Guangdong Provincial Drug Administration, was taken because the affected devices failed to meet relevant quality and safety standards. While no specific inspection dates are provided, the company's proactive recall highlights its response to identified product non-compliance. The recall applies to specific models, specifications, and batches, with full details documented in the Medical Device Recall Event Report Forms. A Class III recall indicates that the use of or exposure to the violative product is not expected to cause adverse health consequences. Foshan Meike Medical Technology Co., Ltd. is undertaking the necessary steps to withdraw the non-compliant products from the market, demonstrating adherence to the regulatory requirements overseen by the NMPA to ensure the safety and efficacy of medical devices.