# China NMPA Product Recall - Electric laparoscopic linear cutting stapler and staple cartridge

Source: https://www.globalkeysolutions.net/records/china_product_recall/ethicon-endo-surgery-llc/46a25932-51a9-4aef-8f8f-36c2f9b6365c/
Source feed: China

> China NMPA product recall for Electric laparoscopic linear cutting stapler and staple cartridge by Ethicon Endo-Surgery, LLC published June 21, 2021. Recall level: Level 3 Recall. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. and its manufacturer, Ethicon Endo-Surgery, L

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its electric laparoscopic linear cutting stapler and staple cartridge.
- Company Name: Ethicon Endo-Surgery, LLC
- Publication Date: 2021-06-21
- Product Name: Electric laparoscopic linear cutting stapler and staple cartridge
- Recall Level: Level 3 Recall
- Recall Reason: A small portion of a batch of electrically operated laparoscopic linear cutting staplers may require replacement due to discrepancies between the packaging specifications and the actual specifications. This replacement may cause minor surgical delays.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ethicon Endo-Surgery, LLC
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. and its manufacturer, Ethicon Endo-Surgery, LLC, initiated a voluntary Level III recall of a specific batch of Electric Laparoscopic Linear Cutting Staplers and Staple Cartridges. This action, reported on June 21, 2021, by the National Medical Products Administration (NMPA), was prompted by a potential discrepancy between the product's packaging specifications and its actual specifications. The primary concern identified was that this packaging error could necessitate device replacement during a procedure, potentially causing minor surgical delays. The recall specifically targets products with Registration Certificate No. 国械注进 (20163212453). The company's proactive recall aims to address and mitigate any risks associated with this packaging inconsistency, ensuring patient safety and product integrity under NMPA oversight. Detailed information regarding affected models and batch numbers is available in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/ethicon-endo-surgery-llc/dfce5be3-6a9d-4239-8ba0-5d5283b81a02/