FDA Device recall Z-0296-2017
Endoscopic Articulating Linear Cutter, 38ATW35
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of Endoscopic Articulating Linear Cutter, 38ATW35 by Ethicon Endo Surgery, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0296-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-15 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | 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 |
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
Reason
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.
Identifiers
| code_info | N91L2N, N91L2P, N91N1J, N91N1K, N91L0T, N91L0U, N91N29, N91N2G, N91R8X, N91R8Y. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0296-2017%22
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