Z-0296-2017Class II

Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic...

Name: Z-0296-2017 Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic...
Creator: Ethicon Endo-Surgery Inc
Published: 2016-07-15
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2016-07-15 / Terminated / root cause: design

FDA source

Ethicon Endo-Surgery Inc began a recall of Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general... on 2016-07-15. FDA classified it as Class II and gives the reason as "Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0296-2017
Classification: Class II
Status: Terminated
Initiated: 2016-07-15
Posted: 2016-10-20
Terminated: 2017-02-28
Recalling firm: Ethicon Endo-Surgery Inc
Product: Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
Product code: GDW Staple, Implantable
Reason for recall: Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.
Root cause tag: design
FDA root cause: Device Design
Action: Ethicon sent an Urgent Medical Device Recall letter dated July 15, 2016, to all affected consignees via UPS next day mail. The letter identified the product, the problem, and the action to be taken by the customer. Consignees were instructed to examine their inventory immediately and quarantine any affected product and return to ENDOPATH. If product subject to the recall was further distributed consignees were instructed to notify the other facility and arrange for return of the affected product. Customer were instructed to complete the Business Reply Form confirming receipt of this letter and fax to Stericycle at 1-888-228-5719 or email to [email protected]. Customers with questions were instructed to contact the Ethicon Customer Support Center at 1-877-384-4266. For questions regarding this recall call 513-337-3582.
Quantity in commerce: 213
Distribution: Worldwide Distribution - US including AL, AR, AZ, CA, CO,CT, DC, FL,GA, IA,IL,KS,KY,LA,MA,MD, ME, MI,MN,MO, MS, MT,NC, ND, NH,NJ, NM, NV, NY, OH, RI, TN, TX, VA, VT, WA, WI and Internationally to Brazil and Canada.
Product codes and lots: N91L2N, N91L2P, N91N1J, N91N1K, N91L0T, N91L0U, N91N29, N91N2G, N91R8X, N91R8Y.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0296-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0295-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20
Z-0296-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-20

Product code GDW

K111111Class IIEndopath Ets 35Mm Endoscopic Linear Cutter and Reloads, and Ets-Flex 35Mm Endoscopic Articulating Linear Cutter and ReloEthicon Endo-Surgery, LLC / cleared 2011-06-08

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)