Merit Medical Systems, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2243-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391

Product Classification:

Class II

Date Initiated: July 21, 2021

Date Posted: August 18, 2021

Recall Number: Z-2243-2021

Event ID: 88352

Reason for Recall:

There is a potential that a package sheath contains an incorrect dilator.

Status: Terminated

Product Quantity: 373 UNITS

Code Information:

Lot # H2069291

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of ID, HI, TX, CA, AZ, MN, UT, KS, MO and the countries of Republic of Korea, Netherlands, Germany, Cyprus, Italy, Sweden, Taiwan, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated