Merit Medical Systems, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1578-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

Product Classification:

Class II

Date Initiated: March 21, 2023

Date Posted: May 17, 2023

Recall Number: Z-1578-2023

Event ID: 92042

Reason for Recall:

Custom sheath Introducer contains incorrect needle size

Status: Ongoing

Product Quantity: 1186 units

Code Information:

Lot # H2122096S1; UDI-DI: (00)884450525197

Distribution Pattern:

US Distribution to state of: Minnesota

Voluntary or Mandated:

Voluntary: Firm initiated