Merit Medical Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0062-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.

Product Classification:

Class II

Date Initiated: August 30, 2024

Date Posted: October 23, 2024

Recall Number: Z-0062-2025

Event ID: 95330

Reason for Recall:

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Status: Ongoing

Product Quantity: 432 devices

Code Information:

Catalog Number: K05T-02159 UDI-DI code: 00884450140840 Lot Number: T2417859 T2434208 T2509792 T2549931 T2561788 T2625814 T2675576 T2762716 T2801089 T2893877

Distribution Pattern:

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated