Z-0461-05

Endopath EZ45 Endoscopic Linear Cutter (ET45G)

Name: Z-0461-05 Endopath EZ45 Endoscopic Linear Cutter (ET45G)
Creator: Ethicon Endo-Surgery
Published: 2004-11-21
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2004-11-21 / Terminated

FDA source

Ethicon Endo-Surgery began a recall of Endopath EZ45 Endoscopic Linear Cutter (ET45G) on 2004-11-21. The reason FDA records is "The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0461-05
Status: Terminated
Initiated: 2004-11-21
Posted: 2005-02-01
Terminated: 2008-10-29
Recalling firm: Ethicon Endo-Surgery Inc
Product: Endopath EZ45 Endoscopic Linear Cutter (ET45G).
Product code: GDW Staple, Implantable
Reason for recall: The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.
FDA root cause: Other
Action: The firm sent letters, dated 11/21/04, to all consignees.
Quantity in commerce: 1456 devices.
Distribution: The product was distributed to hospitals and distributors throughout the United States and to foreign customers located in Korea, China, Republic of Singapore, Argentina, Italy, New Zealand, Austria, Canada, Australia, Brazil, United Arab Emirate, Thailand, Czech Republic, Sweden, Switzerland, Greece, Russia, India, Portugal, Israel, Poland, Hungary, and Uruguay.
Product codes and lots: ET45G: lots T4X78R, T4XEO2, T4YH24, V4Z686, V4Z687, V40493, V4083R, V40E8C, V40J36, V40L12, V40X9T, V41143, V41832, V41A4H, V41U9L, V42505, V42C8X, V42G6R, V42H22, V42K6N, V42L0H, V42M83, V42P08, V42V6G, V42X1P, V42X6J, V4307T, V4ZL7F, V4ZY12, V40Z2Y, .

Product code GDW

K020779Class IIProximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. / cleared 2002-06-05

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)