# China NMPA Product Recall - ECHELON™ Flex Powered Vascular Stapler with Advanced Placement Tip and ENDOPATH EC Vascular White Reload for Advanced Placement Tip

Source: https://www.globalkeysolutions.net/records/china_product_recall/ethicon-endo-surgery-llc/6ebbad8e-4d4f-4dde-bc76-c9d278fe2b5b/
Source feed: China

> China NMPA product recall for ECHELON™ Flex Powered Vascular Stapler with Advanced Placement Tip and ENDOPATH EC Vascular White Reload for Advanced Placement Tip by Ethicon Endo-Surgery, LLC published May 19, 2025. Recall level: Level 1 Recall. Ethicon Endo-Surgery, LLC initiated a voluntary Class I recall of its ECHELON™ Flex Powered Vascular

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ethicon Endo-Surgery, LLC is voluntarily recalling its motorized laparoscopic linear vascular anastomosis device and staple cartridge.
- Company Name: Ethicon Endo-Surgery, LLC
- Publication Date: 2025-05-19
- Product Name: ECHELON™ Flex Powered Vascular Stapler with Advanced Placement Tip and ENDOPATH EC Vascular White Reload for Advanced Placement Tip
- Recall Level: Level 1 Recall
- Recall Reason: The rising trend of complaints about specific batches of products underscores the importance of solutions to the problem of device safety locking.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ethicon Endo-Surgery, LLC
- Summary: Ethicon Endo-Surgery, LLC initiated a voluntary Class I recall of its ECHELON™ Flex Powered Vascular Stapler with Advanced Placement Tip and ENDOPATH EC Vascular White Reload for Advanced Placement Tip. This significant regulatory action was announced through the National Medical Products Administration (NMPA) on May 19, 2025. While the precise reasons prompting the recall are not explicitly detailed in this document, a Class I designation by regulatory bodies like the NMPA indicates a high probability that the use of or exposure to the affected medical device could lead to serious adverse health consequences or even death. The recall encompasses specific models, specifications, and batches of these vascular stapling devices, with comprehensive information available in the attached "Medical Device Recall Report Form." Ethicon Endo-Surgery, LLC is responsible for implementing this recall, which typically involves notifying customers, distributors, and healthcare providers, as well as retrieving all affected products from the market. This voluntary action underscores the company's adherence to stringent medical device safety standards under the NMPA's regulatory framework, aiming to protect patient safety. Further details regarding the required actions and specific scope of the recall are contained within the official report.

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