Merit Medical Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0059-2025)

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:

Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 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-0059-2025

Event ID: 95330

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1,120 devices

Code Information:

Catalog Number: IN2330/B UDI-DI code: 00884450298046 Lot Number: H2369557 H2416390 H2421992 H2426112 H2492843 H2522880 H2540015 H2554505 H2560208 H2579556 H2765640 H2793109 H2806018 H2810777

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