# China NMPA Product Recall - GORE-TEX® Suture

Source: https://www.globalkeysolutions.net/records/china_product_recall/wl-gore-associates-inc/947c7280-f1b3-49a2-8661-b1573f90cad4/
Source feed: China

> China NMPA product recall for GORE-TEX® Suture by W.L. Gore & Associates, Inc. published August 29, 2025. Recall level: Level 3 Recall. W.L. Gore & Associates, Inc., through its subsidiary Gore Industrial Products Trading (Shanghai) Co.

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: W.L. Gore & Associates, Inc. is voluntarily recalling non-absorbable sutures.
- Company Name: W.L. Gore & Associates, Inc.
- Publication Date: 2025-08-29
- Product Name: GORE-TEX® Suture
- Recall Level: Level 3 Recall
- Recall Reason: Incorrect label on outer packaging for a specific product model
- Discovering Company: Gore Industrial Products Trading (Shanghai) Co., Ltd.
- Manufacturing Company: W.L. Gore & Associates, Inc.
- Summary: W.L. Gore & Associates, Inc., through its subsidiary Gore Industrial Products Trading (Shanghai) Co., Ltd., has initiated a voluntary Class III recall of its GORE-TEX® non-absorbable sutures. This action, reported to the National Medical Products Administration (NMPA) and published on August 29, 2025, stems from an identified issue with incorrect labeling on the outer packaging of specific product models. While the manufacturer, W.L. Gore & Associates, Inc., is based internationally, the products implicated in this recall were not imported into the Chinese market, as confirmed by the NMPA document. The regulatory oversight for this medical device is established under National Medical Device Registration Certificate No. 20172021669, falling within the purview of the NMPA in China. The recall signifies the company's proactive measure to address a packaging discrepancy. Specific details regarding the models, specifications, and affected batches are available in the accompanying "Medical Device Recall Event Report Form." No inspection dates are explicitly mentioned in the provided document, indicating this recall was initiated by the company rather than triggered by an NMPA inspection. The required action is the voluntary withdrawal of the identified sutures from the market where they are present, although, in this specific instance, they did not reach China.

Company: https://www.globalkeysolutions.net/companies/wl-gore-associates-inc/69dc2148-4a5b-45c0-833a-70a06acdbc97/