Merit Medical Systems, Inc.: Philips Bridge Prep Kit Ref: K12-09098c Sterile Eo
Recall Summary Merit Medical Systems is recalling Philips Bridge Prep Kits (model K12-09098C) distributed nationwide because the catheter may become difficult to advance over the guidewire during use. This is a prescription-only medical device that was distributed across all U.S. states and the District of Columbia. The FDA classified this as a Class II recall.
- 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/22d89ded-f59a-44da-8ea9-95009930f9e2