Z-1746-2025Class I

Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

Name: Z-1746-2025 Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Creator: Ethicon Endo-Surgery Inc
Published: 2025-04-22
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2025-04-22 / Open, Classified / root cause: design

FDA source

Ethicon Endo-Surgery Inc began a recall of Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35 on 2025-04-22. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1746-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-04-22
Posted: 2025-05-20
Recalling firm: Ethicon Endo-Surgery Inc
Product: Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Product code: GDW Staple, Implantable
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: On April 22, 2025, the firm began to notify affected customers through letters titled, "URGENT: MEDICAL DEVICE CORRECTION." Customers were instructed to notify all users of the affected device and to post a copy of the communication, which reminds users of the Instrument Lockout Instructions that are part of the product IFU. ***UPDATED 8/20/2025*** In May 2025, all customers received an updated letter which stated that Ethicon would also provide in-person training to all impacted US consignees regarding managing a lockout condition.
Quantity in commerce: 678,526
Distribution: US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1746-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1746-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-20

Product code GDW

K141952Class IIEchelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads for AdvancedEthicon Endo-Surgery, Inc. / cleared 2014-11-24

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)