Merit Medical Systems, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0026-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409

Product Classification:

Class II

Date Initiated: October 26, 2018

Date Posted: October 9, 2019

Recall Number: Z-0026-2020

Event ID: 83738

Reason for Recall:

Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)

Status: Terminated

Product Quantity: 88 Kits

Code Information:

Catalog #K12T-03688H - Lot #T1401193 and #T1419935

Distribution Pattern:

U.S.: VA, IL

Voluntary or Mandated:

Voluntary: Firm initiated