Summary
The FDA issued a Class I for NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I by NOXBOX LTD. Reason: 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 d.
Details
Source
Device Recall
External ID
Z-0028-2026
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
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).
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-0028-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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