Class II — Merit Medical Systems, Inc.
| Recalling firm | Merit Medical Systems, Inc. |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | catheter may experience resistance when being advanced over the guidewire |
| Product | Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY |
| Distribution | US Nationwide distribution in the state of CO. |
| Initiated | 2026-04-02 |
| Classified | 2026-04-29 |
| Recall number | Z-2003-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merit Medical Systems, Inc. (Z-2003-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98637/
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