FDAClass II · Medical device · Recalled May 6, 2026

Philips Bridge Prep Kit REF recall — Merit Medical Systems, Inc.

Hazard: catheter may experience resistance when being advanced over the guidewire

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2003-2026
Brand: Merit Medical Systems
Classification: Class II
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

Philips Bridge Prep Kit REF

Companies & origin

Recalling firm location: South Jordan, UT, United States
Firm address: 1600 W Merit Pkwy, 84095-2416

Identifying details (verbatim from the notice)

Product codes / lots: All Lot Numbers/UDI: 00884450816509
Distribution: US Nationwide distribution in the state of CO.
Firm notified the public via: Letter
FDA event ID: 98637
Recall initiated: April 2, 2026
FDA classified: April 29, 2026
FDA report date: May 6, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 4:00 AM UTC.

Report a data error on this page