Recall Z-2553-2025— Merit Medical Systems, Inc.

Name: FDA recall Z-2553-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-25

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2025-07-25. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-07-25
Firm location: South Jordan, UT, United States

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.