Recall Z-2002-2026— Merit Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2026-04-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY. Reason: catheter may experience resistance when being advanced over the guidewire.
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-04-02
- Firm location
- South Jordan, UT, United States
Product description
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
Reason for recall
catheter may experience resistance when being advanced over the guidewire
Data sourced from openFDA. This site is unofficial and independent of the FDA.