NOXBOX LTD: Medical Device Recall in 2025 - (Recall #: Z-0029-2026)

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-0029-2026

Event ID: 97516

Reason for Recall:

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

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