China NMPA Product Recall - Face mask, face mask air, oxygen, nose mask air, oxygen

ResMed Pty Ltd, through its subsidiary ResMed (Beijing) Trading Co., Ltd., initiated a voluntary Level I recall of specific face masks and nasal masks on January 25, 2024. The recall was prompted by the potential for magnetic field interference with certain medical implants, posing a safety risk to users. The affected products include face masks registered under National Medical Device Registration Certificates 20212080001 and 20172081004, and nasal masks under certificate 20152564143. This action falls under the oversight of the National Medical Products Administration (NMPA), emphasizing adherence to national medical device regulations. ResMed has provided a "Medical Device Recall Event Report Form" containing detailed information on models, specifications, and batch numbers for the recalled items, advising stakeholders and affected parties to consult this document for comprehensive guidance and necessary actions related to the recall process.