Merit Medical Systems, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2553-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 25, 2025

Date Posted: September 17, 2025

Recall Number: Z-2553-2025

Event ID: 97420

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.

Status: Ongoing

Product Quantity: 447

Code Information:

Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 Lot Numbers: H3098831 H3111155 H3152503 H3155611 H3186901 MAPTEN42 / 00884450832509 Lot Numbers: H3076189 H3111156 H3152504 H3155614 H3173674 MAPTEN452 / 00884450821329 Lot Number: H3111162

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

Voluntary or Mandated:

Voluntary: Firm initiated