FDAClass IOctober 15, 2025

NOxBOXi Nitric Oxide Delivery System recall

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

Why was NOxBOXi Nitric Oxide Delivery System recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Recalling firm
NOXBOX LTD
Quantity
1667 units
Distribution
Domestic: TN;
Recall date
October 15, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls