# FDA recall Z-2532-2025

> **Contract Medical International GmbH** · Class II · device recall initiated 2025-07-30.

## 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:

## 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.

## Key facts

- **Recall number:** Z-2532-2025
- **Recalling firm:** Contract Medical International GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-30
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dresden, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2532-2025

## Citation

> AI Analytics. FDA recall Z-2532-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2532-2025. Source: US FDA. Licensed CC0.

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