# China NMPA Product Recall - Curved and straight endoscopic anastomotic devices, endoscopic curved endoscopic anastomotic device

Source: https://www.globalkeysolutions.net/records/china_product_recall/ethicon-endo-surgery-llc/8ed507a6-c5ec-40ec-9dc4-78db29a3fa3d/
Source feed: China

> China NMPA product recall for Curved and straight endoscopic anastomotic devices, endoscopic curved endoscopic anastomotic device by Ethicon Endo-Surgery, LLC published May 30, 2019. Recall level: Level 1. Ethicon Endo-Surgery, LLC, through its agent Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Changes to the recall level and quantity of curved and straight endoscopic anastomotic devices, and endoscopic curved endoscopic anastomotic devices by Ethicon Endo-Surgery, LLC.
- Company Name: Ethicon Endo-Surgery, LLC
- Publication Date: 2019-05-30
- Product Name: Curved and straight endoscopic anastomotic devices, endoscopic curved endoscopic anastomotic device
- Recall Level: Level 1
- Recall Reason: Ethicon Endo-Surgery, LLC has confirmed that using curved and straight endoscopic staplers from the aforementioned batches, particularly the curved endoscopic stapler, can lead to uncut gaskets and poor staple formation, which may affect the integrity of the anastomosis suture. If anastomosis suture problems are not adequately addressed or identified, there is a risk of postoperative anastomotic leakage, gastrointestinal injury, bleeding, or hemorrhagic shock.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ethicon Endo-Surgery, LLC
- Summary: Ethicon Endo-Surgery, LLC, through its agent Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a Level 1 recall for its curved and straight endo-surgery staples and endoscopic curved endo-surgery staples. This critical recall, first reported on April 11, 2019, and updated on May 20, 2019, addresses manufacturing defects including uncut gaskets and poor staple formation. These issues significantly compromise the integrity of anastomosis sutures, posing a serious risk of postoperative anastomotic leakage, gastrointestinal injury, bleeding, or hemorrhagic shock to patients.

The regulatory action falls under the National Medical Products Administration (NMPA) framework, identified by Index No. JGXX-2019-10351. The recall level was reclassified to Level 1 due to the severe potential health consequences. A total of 114,501 units were imported into China, with 15,854 units subsequently identified in the company's warehouse awaiting processing.

Required actions include immediate notification and confirmation from affected customers. All unused products within their expiration dates, whether held by customers or in company inventory, must be returned to the central warehouse. These items will then either be shipped back to the manufacturer, Ethicon Endo-Surgery, LLC, or destroyed on-site. All affected products within the company's warehouse have been isolated.

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