Merit Medical Systems, Inc.: Philips Bridge Prep Kit Ref: K12-09098c Sterile Eo

Recall Summary Merit Medical Systems is recalling Philips Bridge Prep Kits (REF: K12-09098C) because the catheter may experience resistance when being advanced over the guidewire during use. This is a Class II recall affecting prescription medical devices distributed nationwide across all U.S. states and Washington D.C.

Recalling firm
Merit Medical Systems, Inc.
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Reason
catheter may experience resistance when being advanced over the guidewire
Classification
Class II
Category
medical device recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-04-02
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide distribution in the state of CO.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/f4c15add-78b5-4272-94a5-e6207d59d102