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

Source: https://www.globalkeysolutions.net/records/china_product_recall/johnson-johnson-shanghai-medical-devices-co-ltd/56d0336e-81e0-4cb0-bfd7-3517366fa5e5/
Source feed: China

> China NMPA product recall for Curved and straight endoscopic anastomotic devices, endoscopic curved endoscopic anastomotic device by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. published May 07, 2019. Recall level: Level 1 Recall. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class I recall of its c

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling curved and straight endoscopic staplers (including curved endoscopic staplers).
- Company Name: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Publication Date: 2019-05-07
- Product Name: Curved and straight endoscopic anastomotic devices, endoscopic curved endoscopic anastomotic device
- Recall Level: Level 1 Recall
- Recall Reason: Because Ethicon Endo-Surgery, LLC has confirmed that the use of curved and straight endoscopic staplers from the aforementioned batches has resulted in uncut gaskets and poor staple formation due to endoscopic curved endoscopic staplers, this may affect the integrity of the anastomosis suture. If anastomosis suture problems are not adequately addressed or detected, postoperative risks may include anastomotic leakage, gastrointestinal injury, bleeding, or hemorrhagic shock.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class I recall of its curved and straight endo-stabilizers and endoscopic curved endo-stabilizers. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, was first published on April 11, 2019, and updated on May 7, 2019, elevating the recall to Level 1, signifying the highest potential for severe health consequences. The core issue, confirmed by Ethicon Endo-Surgery, LLC, involves manufacturing defects such as uncut gaskets and poor staple formation in specific product batches. These critical flaws compromise the integrity of the anastomosis line, leading to significant postoperative risks. Patients may experience anastomotic leakage, gastrointestinal injury, bleeding, or hemorrhagic shock if these device-related problems are not detected or adequately managed. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is actively working to remove the affected devices, identified by Registration Certificate Nos. 20152652249 and 20152650241, from the market to ensure patient safety. Further details on affected models and batches are available in the accompanying recall event report form.

Company: https://www.globalkeysolutions.net/companies/johnson-johnson-shanghai-medical-devices-co-ltd/c552b533-9bb4-43a8-858a-e58faf1dd14e/