Recall of Philips Bridge Prep Kit Due to Catheter Resistance Issue
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit because the catheter may experience resistance when being advanced over the guidewire, affecting devices distributed nationwide in the US.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit due to a potential issue where the catheter may experience resistance when being advanced over the guidewire.
Which Products Are Affected
The affected product is the Philips Bridge Prep Kit with REF: K12-09098C, described as Sterile EO and Rx ONLY. It includes all lot numbers under UDI: 00884450024140. The recall involves devices distributed nationwide in the United States, specifically in the state of Colorado. No product quantity or specific date ranges were provided.
What You Should Do
Consumers should contact Merit Medical Systems, Inc. at their address, 1600 W Merit Pkwy, South Jordan, UT 84095-2416, as the initial notification was made via letter. Follow the firm's instructions for this voluntary recall under number Z-2004-2026.
Why This Matters
This recall highlights potential safety concerns with medical devices that could affect their use in procedures, classified as a Class II recall by the FDA.
Source
This recall is attributed to the FDA under recall number Z-2004-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,092 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 14, 2026.
Frequently Asked Questions
Common questions about this FDA recall.