Trokamed GmbH recalls Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.

Recall date

November 27, 2024

Source

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

Recall number

Z-0714-2025

FDA classification

Class I

Brand / firm

Trokamed GmbH

Sold / distributed

US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .

Why it was recalled

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.