Philips Bridge Prep Kit REF: K12-09098C Sterile EO — Class II medical device recall Z-2003-2026
Ongoing recall by Merit Medical Systems, Inc., reported 2026-05-06, distributed nationwide. catheter may experience resistance when being advanced over the guidewire
| Recall number | Z-2003-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2026-04-02 |
| Classified | 2026-04-29 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00884450816509 |
| Model numbers | K12-09098C |
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Reason for recall
catheter may experience resistance when being advanced over the guidewire
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2003-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.