Recall of Philips Bridge Prep Kit Due to Catheter Resistance Issue

Source: FDA · United States

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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.