PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 7, 2017 Initiated: March 31, 2017 #Z-2174-2017

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Ethicon Endo-Surgery Inc
Units Affected
792 units
Distribution
Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
Location
Blue Ash, OH

Frequently Asked Questions

What product was recalled?
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM. Recalled by Ethicon Endo-Surgery Inc. Units affected: 792 units.
Why was this product recalled?
There is a risk that the pinion gear in the device could fail under extreme use cases.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 7, 2017. Severity: Moderate. Recall number: Z-2174-2017.