Ethicon Endo-Surgery Inc: Medical Device Recall in 2016 - (Recall #: Z-0295-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. 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 Classification:

Class II

Date Initiated: July 15, 2016

Date Posted: October 26, 2016

Recall Number: Z-0295-2017

Event ID: 74701

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.

Status: Terminated

Product Quantity: 105

Code Information:

N91L48, N91L49, N91R40, N91R41, N91U0W, N91U0X

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated