FDA Medical devices recall ·
Philips Bridge Prep Kit recall
- Recall number
- Z-2003-2026
- Date
- (initiated April 2, 2026)
- Company / brand
- Merit Medical Systems, Inc.
1600 W Merit Pkwy, South Jordan, UT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Why was it recalled?
catheter may experience resistance when being advanced over the guidewire
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All Lot Numbers/UDI: 00884450816509
Distribution
US Nationwide distribution in the state of CO.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2003-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.