Medical Device Recall: 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:
Contract Medical International GmbH · July 30, 2025
Reason for Recall
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.
Distribution
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, Spain, Vietnam, Malaysia, Czechia, Thailand, Libya, Great Britain, Chile, Slovakia, Slovenia, Croatia, Sweden, Argentina.
States Affected
NATIONWIDE
Quantity Affected
2500
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2532-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.