ECHELON ENDOPATH recallZ-0834-2024 · Ethicon Endo-Surgery Inc · initiated Dec 11, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ethicon Endo-Surgery Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On December 11, 2023, the firm notified affected consignees through URGENT VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) letters. Customers were instructed to cease use and distribution of affected product lots. Customers should examine their inventory immediately to determine if they have affected product. Affected product should be quarantined. Unused affected product should be returned. If you require any assistance with returning product, please contact Sedgwick at 888-591-5087 and reference Event # 6925. If you have additional questions regarding this voluntary medical device recall, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.
Recall details
- Recall number
- Z-0834-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 11, 2023
- Posted by the FDA
- Jan 26, 2024
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 22,616 (US), 4,476 (OUS)
- Product code
- GDW
- FDA submissions
- K163454
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
Product description
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
Code information (models, lots, serial numbers)
UDI-DI 10705036014928 Lots 442C02 and 442C03
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ECHELON ENDOPATH GST45WEthicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE1 recall1 death163 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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