# China NMPA Product Recall - pneumoperitoneum machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-medical-co-ltd-medical-instruments-co-ltd/252b2b0e-7461-44a3-829b-acbf0b8baed0/
Source feed: China

> China NMPA product recall for pneumoperitoneum machine by Olympus Medical Co., Ltd. Medical Instruments Co., Ltd. published May 08, 2025. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Medical Co., Ltd. Medical Instruments Co., Ltd. voluntarily recalls the insufflator machine
- Company Name: Olympus Medical Co., Ltd. Medical Instruments Co., Ltd.
- Publication Date: 2025-05-08
- Product Name: pneumoperitoneum machine
- Recall Level: Level 2 Recall
- Recall Reason: Some repaired products have inaccurate flow rate readings.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Medical Co., Ltd. Medical Instruments Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Olympus Medical Systems Co., Ltd., as reported by Olympus Trading (Shanghai) Co., Ltd. This action, detailed in NMPA Index No. JGXX-2025-10055 and published on May 8, 2025, addresses insufflator machines manufactured by Olympus. The core issue identified is inaccurate flow rate detection specifically in some repaired products. While the document does not mention specific inspection dates, the recall is a manufacturer-driven response to this performance anomaly.

The affected devices are registered under National Medical Device Registration Certificate No. 20172061144. A critical detail of this recall is the clarification that the particular products subject to this voluntary action were not imported into China. Consequently, the primary required action for the Chinese market focuses on regulatory awareness and reporting, rather than direct retrieval of units from domestic distribution or users. Comprehensive details, including specific models, specifications, and batch numbers, are provided in the attached "Medical Device Recall Report Form" submitted by Olympus Trading (Shanghai) Co., Ltd. This measure reflects Olympus's commitment to product safety standards under the NMPA's regulatory framework.

Company: https://www.globalkeysolutions.net/companies/olympus-medical-co-ltd-medical-instruments-co-ltd/59cb8814-a4d9-4757-95e9-812d9d17a723/