# FDA recall Z-2553-2025

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2025-07-25.

## Product

10Fore Hemostasis Valve  Catalog Number / UDI-DI code:  MAPTEN4 / 00884450821305  MAPTEN42 / 00884450832509  MAPTEN452 / 00884450821329    The 10Fore Hemostasis Valve is intended to maintain hemostasis during the  introduction/withdrawal and use of diagnostic and interventional devices.

## Reason for recall

Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.

## Distribution

Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY, SD, and WI. The countries of  Canada and Korea

## Key facts

- **Recall number:** Z-2553-2025
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-25
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2553-2025

## Citation

> AI Analytics. FDA recall Z-2553-2025. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-2553-2025. Source: US FDA. Licensed CC0.

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