Recall archive / FDA device enforcement
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35 — FDA record Z-1746-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 22, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
- Reason
- 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
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 678,526
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1746-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 28, 2025
- Recall initiation date
- Apr 22, 2025
- Center classification date
- May 20, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.