Contract Medical International GmbH recalls Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath…

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.

On July 30, 2025, the firm notified affected consignees via email. Customers were instructed to verify if the labeling information on received products is consistent. If customers identify incorrect labeling, they should contact Contract Medical International GmbH for replacement.

• FDA enforcement recordOfficial FDA database entry for Z-2532-2025
• FDA 510(k) clearance · K153197The device's official FDA premarket clearance record
• FDA device classification · DYBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1340The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Contract Medical International GmbHSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.