# FDA recall Z-1902-2025

> **Cook Incorporated** · Class I · device recall initiated 2025-05-15.

## Product

Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration).

## Reason for recall

Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1902-2025
- **Recalling firm:** Cook Incorporated
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-15
- **Report date:** 2025-06-25

- **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-1902-2025

## Citation

> AI Analytics. FDA recall Z-1902-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1902-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*