Z-0834-2024Class II

ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic...

Name: Z-0834-2024 ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic...
Creator: Ethicon Endo-Surgery Inc
Published: 2023-12-11
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2023-12-11 / Open, Classified

FDA source

Ethicon Endo-Surgery Inc began a recall of ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology)... on 2023-12-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0834-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-11
Posted: 2024-01-26
Recalling firm: Ethicon Endo-Surgery Inc
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
Product code: GDW Staple, Implantable
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 22,616 (US), 4,476 (OUS)
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
Product codes and lots: UDI-DI 10705036014928 Lots 442C02 and 442C03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0834-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0834-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26

Product code GDW

K163454Class IIECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mmEthicon Endo-Surgery, LLC / cleared 2017-01-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)