Recall Z-2002-2026 ยท OEQ Angiography/Angioplasty Kit
Merit Medical Systems, Inc.
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
| Date | Apr 29, 2026 (initiated Apr 2, 2026) |
| Status | Open, Classified |
| Reason | catheter may experience resistance when being advanced over the guidewire |
| Root cause | Nonconforming Material/Component |
| Action | On April 17, 2026, Merit Medical Issued a Urgent Medical Device Recall notification via: FedEx. Initial notification was issued on April 2, 2026 via E-Mail and FedEx. Merit ask consignees to take the following actions: 1. Ensure that applicable personnel within your organization are made aware of this safety notice. 2. If the product has been further distributed to other facilities, institutions, or manufacturers, please immediately share this safety notice in accordance with your company policies. Please consider communicating the following to your customers: a. For continued safe use of th |
| Distribution | US Nationwide distribution in the state of CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.