NOXBOX LTD: Medical Device Recall in 2025 - (Recall #: Z-0028-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

Product Classification:

Class I

Date Initiated: September 9, 2025

Date Posted: October 15, 2025

Recall Number: Z-0028-2026

Event ID: 97517

Reason for Recall:

Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).

Status: Ongoing

Product Quantity: 1667 units

Code Information:

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

Distribution Pattern:

Domestic: TN

Voluntary or Mandated:

Voluntary: Firm initiated