Contract Medical International GmbH recalls Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386…

Recall date

July 30, 2025

Source

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

Recall number

Z-2532-2025

FDA classification

Class II

Brand / firm

Contract Medical International GmbH

Sold / distributed

Worldwide - US Nationwide distribution in the states of CA, CT, FL, GA, KY, MA, MI, MO, NJ, NY, OR, RI, SC, TN, TX and the countries of Switzerland, Hungary, Italy, France, Denmark, Austria, Australia, Belgium, Poland, Germany, Bulgaria, Kazakhstan, Finland, Ireland, South Korea, Taiwan, Israel, Sp…

Why it was recalled

Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.

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

What was recalled

Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm: