China NMPA Product Recall - Non-invasive ventilator

Respironics Medical Products (Shenzhen) Co., Ltd. has initiated a voluntary Level II recall of its non-invasive ventilators, as reported by the National Medical Products Administration (NMPA) on June 17, 2021. The recall is driven by significant safety concerns related to the polyester polyurethane (PE-PUR) sound-absorbing foam used in these devices. The company identified two main issues: the foam's potential to release particles that could enter the device's air passage and be ingested or inhaled by users, and its capacity to emit certain organic compounds under specific conditions. This action falls under the regulatory oversight of the NMPA, which manages medical product safety in China. The required action involves the prompt removal of affected non-invasive ventilators from circulation. Detailed information regarding the specific models, specifications, and batches involved in this recall is contained within a "Medical Device Recall Event Report Form." This proactive measure aims to protect public health by addressing device material degradation and potential user exposure to harmful substances.