Summary
The FDA issued a Class I for NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I by NOXBOX LTD. Reason: The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without w.
Details
Source
Device Recall
External ID
Z-0029-2026
Action Date
2025-10-15
Status
Ongoing
Category
device
Product Description
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Lot/Code Info: Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.
Quantity Affected: 1667 units
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.
Distribution
Domestic: TN;
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-09
Company
Sittingbourne
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
NOXBOX LTD has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NOXBOX LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NOXBOX LTD have FDA actions?
NOXBOX LTD has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0029-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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