The Recall Desk

FDA (Devices) recall action 97151

Merit Medical Systems, Inc. recalled 4 products on 2025-08-20

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2025-08-20
Critical
0
Units
18,004

Why these products were recalled

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 agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    34 states
  • HighFDA (Devices)··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.

    Product
    Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2025-08-20

    Custom waste management kit tubing may trap air in the line

    Custom Waste Management 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. 858 units affected.

    Product
    Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2025-08-20

    High pressure tubing may separate and trap air in the line

    High Pressure Tubing is being recalled because it may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 8,040 units affected.

    Product
    High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
    Category
    Distribution
    34 states