# China NMPA Product Recall - Ureteral Access Sheath

Source: https://www.keypedia.com/records/china_product_recall/gyrus-acmi-inc/e8c78a8e-1b07-49c6-8f98-d4c681ad0cd4
Source feed: China

> China NMPA product recall for Ureteral Access Sheath by Gyrus ACMI, Inc. published October 17, 2024. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on October 17, 2024, a Class II volunt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Gyrus ACMI, Inc. is voluntarily recalling ureteral sheaths.
- Company Name: Gyrus ACMI, Inc.
- Publication Date: 2024-10-17
- Product Name: Ureteral Access Sheath
- Recall Level: Level 2 Recall
- Recall Reason: Expander tip fracture
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Gyrus ACMI, Inc.
- Summary: The National Medical Products Administration (NMPA) announced on October 17, 2024, a Class II voluntary recall of a ureteral access sheath manufactured by Gyrus ACMI, Inc. The recall was reported by Olympus Trading (Shanghai) Co., Ltd. The primary issue prompting this action is the identified problem of dilator tip breakage associated with the affected medical device, specifically bearing the index number 20162020704. Gyrus ACMI, Inc. has proactively initiated this voluntary removal of the product from the market to address the safety concern. This action is overseen by the NMPA to ensure public health and product quality standards are maintained within the medical device sector. Detailed information regarding specific models, specifications, and affected batch numbers is contained within the 

Company: https://www.keypedia.com/companies/gyrus-acmi-inc/ec473b01-cf91-4de5-8c57-c06ecc877946