Merit Medical Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0629-2024)

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:

Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY

Product Classification:

Class II

Date Initiated: November 6, 2023

Date Posted: January 10, 2024

Recall Number: Z-0629-2024

Event ID: 93461

Reason for Recall:

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Status: Ongoing

Product Quantity: 3 units

Code Information:

REF: IS4-135-30 Lot # H2765720 UDI: 00884450000885 REF: IS4-90-10 Lot # H2765603 UDI: 00884450006504

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated