Merit Medical Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-3191-2024)

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:

Custom Procedure Kit, REF: K12T-11077

Product Classification:

Class II

Date Initiated: August 12, 2024

Date Posted: October 2, 2024

Recall Number: Z-3191-2024

Event ID: 95234

Reason for Recall:

7F sheath introducers labeled as 7.5F

Status: Ongoing

Product Quantity: 24

Code Information:

REF/UDI-DI/Lot (Expiration Date): K12T-11077/00884450457863/T2908313 (01-DEC-2024)

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated