# FDA recall Z-1510-2025

> **Cordis US Corp** · Class II · device recall initiated 2025-03-04.

## Product

Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F,  SterileEO, Rx Only

## Reason for recall

product mix-up; Vascular stent  labeled as one size but contains a different size.

## Distribution

US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan

## Key facts

- **Recall number:** Z-1510-2025
- **Recalling firm:** Cordis US Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-04
- **Report date:** 2025-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami Lakes, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1510-2025

## Citation

> AI Analytics. FDA recall Z-1510-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1510-2025. Source: US FDA. Licensed CC0.

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