Ethicon recalls ECHELON 45mm staple reloads with GST technology due to risk of incomplete tissue stitching during surgery, potentially requiring additional procedures. Affected units include specific product numbers and lots.
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.
Take action
Contact the company
📍Recalling firmEthicon Endo-Surgery Inc4545 Creek Rd · Blue Ash, OH 45242-2803
“Ethicon Endo-Surgery Recalls ECHELON 45mm Staple Reloads for Incomplete Tissue Stitching.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56579-ethicon-endo-surgery-recalls-echelon-45mm-staple-reloads-for-incomplete. Based on FDA recall #Z-0834-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0834-2024%22&limit=1).
Ethicon Endo-Surgery Inc recalled ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST) and related staplers due to potential incomplete staple line formation, the FDA said on Dec. 11, 2023. The recall was voluntary and initiated by the firm.
How to tell if you have it
Brand: Ethicon
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
UDI-DI: 10705036014928
Lots: 442C02 and 442C03
The hazard
The devices have the potential for incomplete staple line formation during firing, which may lead to insufficient tissue apposition requiring surgical intervention. This issue could result in bleeding, prolonged surgery, or surgical delay.
Context
GovInfoNow's records show Ethicon Endo-Surgery Inc has 12 other recalls on record since Oct. 23, 2017. Other recent recalls of similar products include Ethicon ECHELON LINEAR Cutters Reload 80mm Blue (Sept. 11, 2025), Ethicon Endopath Echelon Vascular White Reload (April 22, 2025), and Ethicon Harmonic HD 1000i Shears (July 20, 2021). Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device (March 3, 2026), Intuitive 8 mm SureForm 30 Gray Reloads (March 11, 2026), and Boston Scientific Suture Cinch Long 1pk Endoscopic Device (July 14, 2026).
How to tell if you have this one
Check for product numbers GST45W and UDI-DI 10705036014928 on the reloads. The affected lots are 442C02 and 442C03.
Brand
Ethicon
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product number (GST45W) and UDI-DI code (10705036014928) on the reloads.
Contact Manufacturer
Reach out to Ethicon Endo-Surgery for guidance on next steps if you have the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada and Brazil.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 58 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0834-2024 (December 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0834-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.