Merit Medical Systems, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1434-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

Product Classification:

Class II

Date Initiated: January 27, 2025

Date Posted: April 2, 2025

Recall Number: Z-1434-2025

Event ID: 96292

Reason for Recall:

Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

Status: Ongoing

Product Quantity: 40

Code Information:

UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24

Distribution Pattern:

International distribution to the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated