China NMPA Product Recall - Ventilator

The National Medical Products Administration (NMPA) issued a Class I voluntary recall notice, published on July 2, 2025, concerning ventilators manufactured by Newport Medical Instruments, Inc. This action, reported by Covidien International Trading (Shanghai) Co., Ltd., addresses a critical safety concern related to devices registered under National Medical Device Registration No. 20123541252 (Revised). The core issue involves a defect in the circuit board assembly, specifically the failure of two independent capacitors. This malfunction could lead to two severe outcomes: either the complete shutdown of the ventilation process, requiring immediate alternative breathing support, or the failure of the alarm system to sound during such a shutdown, potentially leaving healthcare providers unaware of a critical device failure. Given these serious potential health risks, the Class I designation indicates the highest level of recall urgency. Newport Medical Instruments, Inc. is taking corrective action through this voluntary recall, and detailed information regarding affected product models, specifications, and batch numbers is provided in the accompanying "Medical Device Recall Event Report Form."