# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/newport-medical-instruments-inc/c3e11859-34dd-43f6-9c42-70e650ba2d1d/
Source feed: China

> China NMPA product recall for Ventilator by Newport Medical Instruments, Inc. published July 02, 2025. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) issued a Class I voluntary recall notice, publis

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Newport Medical Instruments, Inc. has initiated a voluntary recall of products including ventilators.
- Company Name: Newport Medical Instruments, Inc.
- Publication Date: 2025-07-02
- Product Name: Ventilator
- Recall Level: Level 1 Recall
- Recall Reason: In the event of a malfunction, the two independent capacitors on the circuit board assembly of a specific serial number product may result in two different outcomes: either the capacitors are shut off during the breathing process, requiring the use of alternative ventilation methods; or the alarm is shut off and fails to sound effectively during the shutdown period.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Newport Medical Instruments, Inc.
- Summary: 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."

Company: https://www.globalkeysolutions.net/companies/newport-medical-instruments-inc/39a69fc8-9843-4fff-a985-4f28bdeddee3/