Endoscopic Articulating Linear Cutter — Class II medical device recall Z-0295-2017
Terminated recall by Ethicon Endo-Surgery Inc, reported 2016-10-26, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. Quality control identified a component issue where the pinion gear in the device could fail under extreme use
| Recall number | Z-0295-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Blue Ash, OH, United States |
| Recall initiated | 2016-07-15 |
| Classified | 2016-10-20 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2017-02-28 |
| Distributed | 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 |
| Countries outside the US | BR, CA |
| Quantity | 105 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0295-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.