Philips Bridge Prep Kit REF: K12-09098B Sterile EO recall (Merit Medical Systems, Inc.)
Medical deviceClass IIOngoing
Summary: Merit Medical Systems, Inc. is recalling Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY. Reason: catheter may experience resistance when being advanced over the guidewire.
What is being recalled
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
Why
catheter may experience resistance when being advanced over the guidewire
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the state of CO.
How to tell if yours is affected
All Lot Numbers/UDI: 00884450771310
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2002-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 2, 2026 |
| Reported | May 6, 2026 |
| Company | Merit Medical Systems, Inc. |
| Company location | South Jordan, UT, United States |
| Initiated by | Voluntary: Firm initiated |
More recalls from Merit Medical Systems, Inc. · all medical device recalls · recalls from April 2026