Merit Medical Systems Philips Bridge Prep Kit
Philips Bridge Prep Kit may experience resistance when advanced over a guidewire.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Merit Medical Systems, Inc., of South Jordan, Utah, recalled the Philips Bridge Prep Kit because the catheter may experience resistance when being advanced over the guidewire. The company began the recall on April 2, 2026, and the FDA added it to the Enforcement Report on April 29, 2026. The recall involves the Philips Bridge Prep Kit with REF: K12-09098C and REF: K12-09098B, distributed in the state of Colorado.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
- UDI-DI
- 00884450816509
- 00884450024140
- Lot
- All Lot Numbers/UDI: 00884450024140
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
- UDI-DI
- 00884450771310
- Lot
- All Lot Numbers/UDI: 00884450771310
Details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Colorado.
- Event ID
- 98637
- Recall numbers
- Z-2002-2026 to Z-2004-2026
- Company
- Merit Medical Systems, Inc.South Jordan, Utah
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
