# FDA recall Z-0499-2025

> **Cook Incorporated** · Class II · device recall initiated 2024-10-14.

## Product

Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

## Reason for recall

Devices from the affected device lots have labels that state the incorrect expiration dates.

## Distribution

International Distribution to: Korea only

## Key facts

- **Recall number:** Z-0499-2025
- **Recalling firm:** Cook Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-14
- **Report date:** 2024-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0499-2025

## Citation

> AI Analytics. FDA recall Z-0499-2025. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0499-2025. Source: US FDA. Licensed CC0.

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