CLASS II Device recall · Reported 7 Jun 2017 · FDA Enforcement Report

Endopath Ets-flex Endoscopic Articulating Linear Cutter recalled

Ethicon Endo-Surgery is recalling Endopath Ets-flex Endoscopic Articulating Linear Cutter, Vascular/Thin. The recall was initiated on 31 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesN91U0W, N91U0X, N91L2P, N91N1J, and N91N2G

Quantity recalled792 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2174-2017
FDA event ID: 76921
Recalling firm: Ethicon Endo-Surgery, Blue Ash, OH
Classification: Class II
Status: Terminated
Recall initiated: 31 Mar 2017
FDA classified: 31 May 2017
Reported: 7 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

31 Mar 2017	Recall initiated by company
31 May 2017	Classified by FDA	+61 days
7 Jun 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a risk that the pinion gear in the device could fail under extreme use cases.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.

Questions about this recall

Is Endopath Ets-flex Endoscopic Articulating Linear Cutter, Vascular/Thin recalled?

Yes. Ethicon Endo-Surgery recalled Endopath Ets-flex Endoscopic Articulating Linear Cutter, Vascular/Thin on 31 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-2174-2017.

Why was it recalled?

There is a risk that the pinion gear in the device could fail under extreme use cases.

Which lots are affected?

N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G

Where was it sold?

Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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