Merit Medical Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1826-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Product Classification:

Class II

Date Initiated: June 4, 2015

Date Posted: July 1, 2015

Recall Number: Z-1826-2015

Event ID: 71519

Reason for Recall:

Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.

Status: Terminated

Product Quantity: 1,445

Code Information:

Catalo Number PR0-6F-11-038, Lot Number H767887

Distribution Pattern:

Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany.

Voluntary or Mandated:

Voluntary: Firm initiated