The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2294-2025·Announced 2025-08-20

Custom tubing kits recalled because high pressure tubing may trap air

Custom Tubing Kits under REF K04-00417, K04-00963 and K04-01029 are recalled because high pressure tubing may separate from its connector and trap air that could reach the patient. 2,779 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; air introduced into a patient line is a stated potential harm and the notice reports no injuries.

Plain-English summary

Custom Tubing Kits under REF numbers K04-00417, K04-00963 and K04-01029 are being recalled, with UDI-DI numbers 00884450046630, 00884450046760 and 00884450148938 and lot numbers including I3114667, I3147550, H3117053, H3138590, H3154108, H3162244 and H3181994. The recall covers 2,779 units distributed across 34 states.

The high pressure tubing may relax over time, causing it to partially separate from the connector and leaving a void that can trap air in the line. Use of an affected product may result in that trapped air being introduced into the patient. The FDA classified the action as Class II.

Hospitals and clinics holding these REF numbers should check the lot numbers against the recall notice, quarantine affected stock and follow the manufacturer's instructions for return or replacement.

The recalled product

Product
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Infusion Tubing
Hazard
Affected units
2,779

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.

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 →

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