← FDA ENFORCEMENT
Z-2003-2026Class II
Merit Medical Systems, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Merit Medical Systems, Inc.
Product type
Device
Status
Ongoing
Report date
2026-05-06
Distribution
US Nationwide distribution in the state of CO.
Firm state
UT
Initiated by
Voluntary: Firm initiated
Reason for recall
catheter may experience resistance when being advanced over the guidewire
Product description
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Code / lot info
All Lot Numbers/UDI: 00884450816509
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →