# FDA recall Z-0845-2025

> **Coloplast Manufacturing US, LLC** · Class II · device recall initiated 2024-12-02.

## Product

X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.

## Reason for recall

A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

## Distribution

US Nationwide. Canada.

## Key facts

- **Recall number:** Z-0845-2025
- **Recalling firm:** Coloplast Manufacturing US, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-02
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0845-2025

## Citation

> AI Analytics. FDA recall Z-0845-2025. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0845-2025. Source: US FDA. Licensed CC0.

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