Recall archive / FDA device enforcement
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cut... — FDA record Z-0834-2024
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 Dec 11, 2023. 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 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
- Reason
- There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
- Classification
- Class II
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 22,616 (US), 4,476 (OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0834-2024
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 10705036014928 Lots 442C02 and 442C03 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
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
- Feb 7, 2024
- Recall initiation date
- Dec 11, 2023
- Center classification date
- Jan 26, 2024
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.