Merit Medical Systems, Inc.: Device Recall
Recall #Z-2553-2025 · 07/25/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2553-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Merit Medical Systems, Inc.
- Status
- Ongoing
- Date Initiated
- 07/25/2025
- Location
- South Jordan, UT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 447
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.
Product Description
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.
Distribution Pattern
Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY, SD, and WI. The countries of Canada and Korea
Other Recalls by Merit Medical Systems, Inc.
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.