# 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/fd80b68b-52f4-404d-9a36-5ef81a5f9b43/
Source feed: China

> China NMPA product recall for Disposable laparoscopic pre-positioned chip cutting stapler cartridge Signia Small Diameter Reloads by Covidien llc published March 29, 2024. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) announced a Class I voluntary recall initiated b

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien LLC is voluntarily recalling the cartridges of a single-use laparoscopic pre-embedded chip cutting stapler.
- Company Name: Covidien llc
- Publication Date: 2024-03-29
- Product Name: Disposable laparoscopic pre-positioned chip cutting stapler cartridge Signia Small Diameter Reloads
- Recall Level: Level 1 Recall
- Recall Reason: Under certain conditions, reinstallation may result in uncontrolled movement of the joint head.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: The National Medical Products Administration (NMPA) announced a Class I voluntary recall initiated by Covidien LLC for its single-use laparoscopic pre-embedded chip cutting staple cartridge, specifically Signia Small Diameter Reloads (National Medical Device Registration Certificate No. 20233010130). This recall, reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. and published on March 29, 2024, addresses a critical product safety concern.
The primary issue identified is the potential for "uncontrolled movement of the articular head" when the device is reloaded under specific conditions. This malfunction poses a significant risk to patient safety, warranting the highest level of recall (Class I) due to the strong likelihood of serious adverse health consequences. As a required action under the NMPA's regulatory framework, Covidien LLC is voluntarily recalling affected product models, specifications, and batch information. Detailed information regarding the specific batches subject to this recall is provided in the accompanying "Medical Device Recall Event Report Form." This proactive measure aims to mitigate potential risks and ensure the safety and efficacy of medical devices in the market.

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