Merit Medical Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1956-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.

Product Classification:

Class II

Date Initiated: September 12, 2019

Date Posted: May 20, 2020

Recall Number: Z-1956-2020

Event ID: 85342

Reason for Recall:

labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.

Status: Terminated

Product Quantity: 15 kits

Code Information:

Catalog Number: K21-00031, Lot Number: H1583914, UDI: 00884450426357

Distribution Pattern:

US Nationwide distribution in the state of MI.

Voluntary or Mandated:

Voluntary: Firm initiated