Z-1641-2015Class II

ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip

Name: Z-1641-2015 ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip
Creator: Ethicon Endo-Surgery Inc
Published: 2015-02-26
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2015-02-26 / Terminated / root cause: software

FDA source

Ethicon Endo-Surgery Inc began a recall of ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive... on 2015-02-26. FDA classified it as Class II and gives the reason as "During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1641-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-26
Posted: 2015-05-21
Terminated: 2015-11-17
Recalling firm: Ethicon Endo-Surgery Inc
Product: ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
Product code: GDW Staple, Implantable
Reason for recall: During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Ethicon sent an Urgent Medical Device Recall letter dated February 27, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine your inventory immediately to determine if you have recalled product on hand, remove and quarantine the recalled product, communicate the issue to relevant operating room or materials management personnel or anyone else in your facility who needs to be informed, if any product included in this recall has been forwarded to another facility, contact that facility to arrange return, and complete the Business Reply Form (BRF) (Attachment B) confirming receipt of this notice within three (3) business days. The BRF may be sent to Stericycle by fax at 1-800-807-5967or by email at [email protected]. Please return the BRF even if you do not have affected product. For clinical or product support, please contact your local sales representative or call our Customer Support Center at 1-877-ETHICON (1-877-384-4266) (7:30 a.m. 6:30 p.m. EST). If you need additional shipping labels or a communications package, contact Stericycle at 1-877-643-8419 (8:00 a.m. 5:00 p.m. EST) and reference Event 8760.
Quantity in commerce: 6,744 devices
Distribution: Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, CO, DE, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI and the country of Hong Kong.
Product codes and lots: M/N: VASECR35; Product Lot L4FF3W, Expiry Date 2017-11; Product Lot L4FF3X, Expiry Date 2017-11; Product Lot L4FF3Y, Expiry Date 2017-11; Product Lot M4H046, Expiry Date 2017-12; Product Lot M4H105, Expiry Date 2017-12; Product Lot M4H27D, Expiry Date 2017-12; Product Lot M4H30H, Expiry Date 2017-12; Product Lot M4H37J, Expiry Date 2017-12; Product Lot M4H399, Expiry Date 2017-12; Product Lot M4H589, Expiry Date 2018-01; Product Lot M4H54M, Expiry Date 2018-01; Product Lot M4H643, Expiry Date 2018-01 & Product Lot M4H691, Expiry Date 2018-01..

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1641-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1641-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)