🔍 RecallPedia

Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

Class I - Dangerous
🏥 Medical Devices Recalled: April 22, 2025 Ethicon Endo-Surgery Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI GTIN 10705036014591 Packaging Batches: 917C65 895C93 918C15 938C92 936C69 929C38 948C78 990C81 979C81 400D82 962C74 506D29 379D80 413D56 418D41 419D47 415D43 427D07 434D35 442D78 442D83 444D96 456D87 455D03 493D27 468D88 482D30 502D90 489D62 134D80 112D03 155D33 159D49 181D11 194D77 125D04 167D13 223D59 175D72 234D11 238D70 261D10 270D69 317D74 194D76 349D54 347D73 317D73 356D54 326D66 319D76 338D99 336D39 356D53 367D26 378D04 214D17
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Ethicon Endo-Surgery Inc
Reason for Recall:
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

Product Codes/Lot Numbers:

UDI-DI GTIN 10705036014591 Packaging Batches: 917C65 895C93 918C15 938C92 936C69 929C38 948C78 990C81 979C81 400D82 962C74 506D29 379D80 413D56 418D41 419D47 415D43 427D07 434D35 442D78 442D83 444D96 456D87 455D03 493D27 468D88 482D30 502D90 489D62 134D80 112D03 155D33 159D49 181D11 194D77 125D04 167D13 223D59 175D72 234D11 238D70 261D10 270D69 317D74 194D76 349D54 347D73 317D73 356D54 326D66 319D76 338D99 336D39 356D53 367D26 378D04 214D17

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1746-2025

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