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

Custom manifold kit tubing may separate and trap air in line

Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Risk-of-harm product: trapped air that the notice says may be introduced into the patient, with no injury reported in the source.

Plain-English summary

The Custom Manifold Kit is being recalled across the REFs listed in the recall notice, including K09-02239C, K09-02249UP, K09-09110B and K09-10294A. The action covers 6,327 units, identified by the UDI-DI codes and lot numbers in the notice.

The stated reason is that the 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. According to the notice, use of the affected product may result in the trapped air being introduced into the patient. The FDA classified the action as Class II. The source does not report any injury having occurred.

Distribution was nationwide in the United States, including Ohio, California, South Dakota, Virginia, Arizona, Montana, Texas, Michigan and Florida. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the REFs, UDI-DI codes and lot numbers above and follow the instructions issued by the manufacturer.

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 — Fluid management kit
Hazard
Affected units
6,327

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.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

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Same hazard · tubing separation

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