The Recall Desk
Severity pendingFDA (Devices)·Z-2295-2025·Announced 2025-08-20

Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B,

Pending LLM rewrite. Source: FDA_DEVICE Z-2295-2025.

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 Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
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 (20)

  • REF/UDI-DI/Lot(Expiration): K09-02239C/00884450204313/H3111528(10/31/2027)
  • H3157165(10/31/2027)
  • K09-02249UP/00884450330043/H3116232(8/26/2026)
  • H3156392(8/31/2026)
  • H3173422(8/31/2026)
  • H3178693(8/31/2026)
  • H3190348(3/16/2028)
  • H3195871(3/31/2028)
  • H3205105(4/7/2028)
  • K09-09110B/00884450279076/H3163891(3/21/2028)
  • K09-10294A/ 00884450210000/H3169190(4/30/2027)
  • K09-11227A/00884450210697/H3156393(2/10/2028)
  • H3157208(2/17/2028)
  • K09-11456B/00884450279717/H3112605(8/31/2026)
  • H3156272(8/31/2026)
  • K09-12123B/00884450741146/H3167049(3/2/2028)
  • K09-13342AP/00884450548714/H3119448(10/31/2027)
  • H3127766(10/31/2027)
  • H3152497(1/25/2028)
  • H3152498(1/25/2028)

Distribution

Distributed nationwide across the United States.

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