# China NMPA Product Recall - Disposable laparoscopic pre-positioned chip cutting stapler cartridge Signia Small Diameter Reloads

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/67e81bae-fcbd-4dd5-ac67-ac6ffd1db010/
Source feed: China

> China NMPA product recall for Disposable laparoscopic pre-positioned chip cutting stapler cartridge Signia Small Diameter Reloads by Covidien llc published October 21, 2025. Recall level: Level 3 Recall. Covidien LLC, the manufacturer, in cooperation with Covidien Medical Devices International Trading (

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien LLC is voluntarily recalling its single-use laparoscopic pre-embedded chip cutting stapler cartridge, Signia Small Diameter Reloads.
- Company Name: Covidien llc
- Publication Date: 2025-10-21
- Product Name: Disposable laparoscopic pre-positioned chip cutting stapler cartridge Signia Small Diameter Reloads
- Recall Level: Level 3 Recall
- Recall Reason: There are internal manufacturing problems in the outer shell tube pressing process.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: Covidien LLC, the manufacturer, in cooperation with Covidien Medical Devices International Trading (Shanghai) Co., Ltd., has initiated a voluntary Class III recall for its "Single-Use Laparoscopic Pre-embedded Chip Cutting Staple Cartridge Signia Small Diameter Reloads." This significant action was publicly announced on October 21, 2025, under the oversight of the National Medical Products Administration (NMPA). The recall addresses a specific and critical manufacturing issue pertaining to the outer shell tube pressing process of the device. This internal manufacturing defect prompted the company to take immediate corrective measures. The affected product, which holds National Medical Device Registration Certificate No. 20233010130, is being recalled to uphold product quality and patient safety standards. The regulatory framework under which this recall is conducted emphasizes accountability for medical device manufacturers in China. The main violation or issue centers on internal process control deficiencies during the manufacturing phase. The required actions involve Covidien LLC and its affiliated entities systematically identifying and retrieving all impacted product models, specifications, and batch numbers from distribution channels and end-users. This proactive recall demonstrates the company's commitment to regulatory compliance and product integrity within the medical device sector.

Company: https://www.globalkeysolutions.net/companies/covidien-llc/5111c5da-0a3d-4895-b59e-e49f0ad3547d/