The Recall Desk
CriticalFDA (Devices)·Z-0029-2026·Announced 2025-10-15

Nitric oxide systems recalled over fault from rapid button presses

NOxBOX is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems because a rapid succession of button selections can trigger an unexpected internal fault or system diagnostic error.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.

Plain-English summary

The NOxBOXi Nitric Oxide Delivery System, model NOXBOX-I, is being recalled over a user interface fault.

An unexpected internal fault or system diagnostic error can result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.

The recall covers 1,667 units, distributed in Tennessee. The device carries model numbers NOXBOXI from the manufacturer and REQNOXBOXI from the US distributor. The FDA has classified the recall as Class I.

Clinicians using the system should follow the manufacturer's instructions and allow the device to respond to each prompt before making the next selection.

The recalled product

Product
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Manufacturer
NOXBOX LTD
Category
Medical Device — Gas delivery system
Hazard
  • system-fault
  • user-interface
  • nitric-oxide
  • device-error

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 (4)

  • Model Numbers: (1) NOXBOXI (NBL (Manufacturer))
  • (2) REQNOXBOXI (Linde (U.S. Distributor))
  • UDI-DI: 05060541640009
  • All serial numbers.

Distribution

Distributed in 1 state:

  • TN

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