Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2294-2025 — Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029

U.S. FDA — Device Enforcement · United States · 2025-06-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2294-2025
Date of alert
2025-06-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Merit Medical Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884450046630
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.