Z-2532-2025Class II

Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog...

Name: Z-2532-2025 Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog...
Creator: Contract Medical International GmbH
Published: 2025-07-30
License: https://open.fda.gov/license/

Contract Medical International GmbH / initiated 2025-07-30 / Open, Classified / root cause: labeling and UDI

FDA source

Contract Medical International GmbH began a recall of Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress... on 2025-07-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2532-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-30
Posted: 2025-09-05
Recalling firm: Contract Medical International GmbH
Product: 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:
Product code: DYB Introducer, Catheter
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 2500
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.
Product codes and lots: Lot Code: Model Number: 386594 Lot Number: 800989 Unique Device Identifier: 04251244503703 Expiration Date: 31 OCT 2027.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2532-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2532-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-05

Product code DYB

K153197Class IIFortress Introducer Sheath SYstemContract Medical International, GmbH / cleared 2016-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)