FDA Device recall Z-2003-2026
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY by Merit Medical Systems, citing catheter may experience resistance when being advanced over the guidewire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2003-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-02 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Reason
catheter may experience resistance when being advanced over the guidewire
Identifiers
| code_info | All Lot Numbers/UDI: 00884450816509 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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All Merit Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2003-2026%22
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