Home / Recalls / Merit Medical Systems, Inc. / Z-2004-2026

Z-2004-2026 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
May 6, 2026
Initiation Date
April 2, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

Reason for Recall

catheter may experience resistance when being advanced over the guidewire

Distribution Pattern

US Nationwide distribution in the state of CO.

Code Information

All Lot Numbers/UDI: 00884450024140

Other recalls by Merit Medical Systems, Inc.

  • Z-2002-2026 Class II — Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY (April 2, 2026)
  • Z-2003-2026 Class II — Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY (April 2, 2026)
  • Z-1577-2026 Class I — 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-0 (February 13, 2026)
  • Z-1576-2026 Class I — ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419 (February 13, 2026)
  • Z-1575-2026 Class I — CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENF (February 13, 2026)
  • Z-1578-2026 Class I — DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H7 (February 13, 2026)
  • Z-1579-2026 Class I — BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU (February 13, 2026)
  • Z-1123-2026 Class II — Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: (December 4, 2025)
  • Z-1129-2026 Class II — Allwell Angioplasty Pack REF: IS-30-B1/B (December 4, 2025)
  • Z-1124-2026 Class II — Allwell Inflation Device, for angiographic use REF: IS-30-A (December 4, 2025)