Ethicon Endo-Surgery Inc recalls Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM

Recall date

March 31, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2174-2017

FDA classification

Class II

Brand / firm

Ethicon Endo-Surgery Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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