Merit Medical Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0628-2024)

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:

Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY

Product Classification:

Class II

Date Initiated: November 6, 2023

Date Posted: January 10, 2024

Recall Number: Z-0628-2024

Event ID: 93461

Reason for Recall:

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

Status: Ongoing

Product Quantity: 59 units

Code Information:

Ref:28HC17130SN - Lot# H2769793 - UDI:00884450315453 REF: 28HC17150ST/A - Lot# H2767389 - UDI:00884450358566 REF: 29HC2015045/A - Lot # H2750582 - UDI: 00884450358726 Ref: 29HC20150SN/A - Lot# H2750587 - UDI: 00884450358733 29HC20150ST H2765980 00884450315408

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