Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Pending LLM rewrite. Source: FDA_DEVICE Z-2294-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
The recalled product
- Product
- Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- REF/UDI-DI/Lot(Expiration): K04-00417/00884450046630/I3114667(12/10/2027)
- I3147550(1/28/2028)
- K04-00963/00884450046760/H3117053(12/14/2027)
- H3138590(1/20/2028)
- H3154108(2/10/2028)
- H3154786(2/10/2028)
- H3162244(2/19/2028)
- H3166789(3/2/2028)
- H3173526(3/23/2028)
- K04-01029/00884450148938/H3117059(12/17/2027)
- H3154112(2/10/2028)
- H3159017(2/19/2028)
- H3166777(3/9/2028)
- H3181994(4/1/2028)
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22