Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00…

Recall date

July 25, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2553-2025

FDA classification

Class II

Brand / firm

Merit Medical Systems, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.