Home / Recalls / Merit Medical Systems, Inc. / Z-1434-2025

Z-1434-2025 Class II Ongoing

Recalled by Merit Medical Systems, Inc. — South Jordan, UT

Recall Details

Product Type
Devices
Report Date
April 2, 2025
Initiation Date
January 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40

Product Description

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

Reason for Recall

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

Distribution Pattern

International distribution to the country of Japan.

Code Information

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

Other recalls by Merit Medical Systems, Inc.

  • Z-1124-2026 Class II — Allwell Inflation Device, for angiographic use REF: IS-30-A (December 4, 2025)
  • Z-1125-2026 Class II — Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 (December 4, 2025)
  • Z-1129-2026 Class II — Allwell Angioplasty Pack REF: IS-30-B1/B (December 4, 2025)
  • Z-1123-2026 Class II — Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: (December 4, 2025)
  • Z-1126-2026 Class II — Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05- (December 4, 2025)
  • Z-1127-2026 Class II — Merit Medical , Custom Manifold Kit REF: K09-13203A (December 4, 2025)
  • Z-1128-2026 Class II — Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 (December 4, 2025)
  • Z-0533-2026 Class II — PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9 (August 4, 2025)
  • Z-2553-2025 Class II — 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 (July 25, 2025)
  • Z-2294-2025 Class II — Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029 (June 5, 2025)