Z-2174-2017Class II

Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM

Name: Z-2174-2017 Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Creator: Ethicon Endo-Surgery Inc
Published: 2017-03-31
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2017-03-31 / Terminated / root cause: manufacturing process

FDA source

Ethicon Endo-Surgery Inc began a recall of Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM on 2017-03-31. FDA classified it as Class II and gives the reason as "There is a risk that the pinion gear in the device could fail under extreme use cases". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2174-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-31
Posted: 2017-05-31
Terminated: 2018-05-03
Recalling firm: Ethicon Endo-Surgery Inc
Product: Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Product code: GDW Staple, Implantable
Reason for recall: There is a risk that the pinion gear in the device could fail under extreme use cases.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were sent notification letters and were asked to complete the Business Reply Form (BRF).
Quantity in commerce: 792 units
Distribution: Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
Product codes and lots: N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2174-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2174-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-05-31

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)