The Recall Desk
HighFDA (Devices)·Z-2293-2025·Announced 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.

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

High Pressure Tubing, REF 502211002, HP9720E/C and HP9721E/C, is being recalled. The action covers 8,040 units, identified by the UDI-DI codes and lot numbers in the recall 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 tubing is supplied to healthcare facilities rather than sold to consumers.

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

The recalled product

Product
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — High pressure tubing
Hazard
Affected units
8,040

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 (5)

  • REF/UDI-DI/Lot(Expiration): 502211002/I3116954(8/16/2028)
  • HP9720E/C/00884450859889/I3116059(12/10/2027)
  • I3127321(12/30/2027)
  • I3137220(1/28/2028)
  • HP9721E/C/00884450859896/I3116060(12/10/2027)

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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