# China NMPA Product Recall - Electronic upper gastrointestinal endoscope, electronic colon endoscope, electronic duodenoscope, electronic colon endoscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-medical-corporation/8fcfb227-cfd8-423b-a28e-cefb28200254/
Source feed: China

> China NMPA product recall for Electronic upper gastrointestinal endoscope, electronic colon endoscope, electronic duodenoscope, electronic colon endoscope by Olympus Medical Corporation published August 21, 2024. Recall level: Level 2 Recall. On August 21, 2024, the National Medical Products Administration (NMPA) issued a notice regarding a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Medical Corporation has initiated a voluntary recall of products including electronic upper gastrointestinal endoscopes.
- Company Name: Olympus Medical Corporation
- Publication Date: 2024-08-21
- Product Name: Electronic upper gastrointestinal endoscope, electronic colon endoscope, electronic duodenoscope, electronic colon endoscope
- Recall Level: Level 2 Recall
- Recall Reason: The product in question had issues such as leftover white protective tape after repair.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Medical Corporation
- Summary: On August 21, 2024, the National Medical Products Administration (NMPA) issued a notice regarding a voluntary Level II product recall initiated by Olympus Medical Corporation, as reported by Olympus Trading (Shanghai) Co., Ltd. This action targets several electronic endoscope product lines, including upper gastrointestinal endoscopes, colonoscopes, duodenoscopes, and colorectal endoscopes. The primary issue prompting this recall is the discovery of white protective tape residue remaining on the devices after repairs, indicating a potential quality control concern in the manufacturing process. The recall involves specific imported item numbers, highlighting a manufacturing-level issue with these medical devices. While Olympus Medical Corporation is the manufacturer, the NMPA document explicitly states that none of the products implicated in this specific recall were imported into the Chinese market. The required action by the company is a voluntary Level II recall to address the identified product quality defect. This action underscores the regulatory oversight of the NMPA in ensuring medical device safety and requiring manufacturers to uphold rigorous product quality standards within their operations. Further details on affected models and batches are available in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/olympus-medical-corporation/527e2e59-6901-42c2-a360-40be55f6edb8/