Lower riskMedical device recall · FDA · Published September 9, 2025
NOXBOX Nitric Oxide Delivery System Recall: Button Errors Cause System Fault
NOXBOX recalls NOxBOXi Nitric Oxide Delivery System (model NOXBOX-I) due to button errors causing internal system faults. Affected units include all serial numbers and specific model numbers.
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.
NOXBOX is recalling its NOxBOXi Nitric: Nitric Oxide Delivery System (model NOXBOX-I) because rapid button presses without waiting for the device to respond can cause internal system errors. This could lead to the device malfunctioning, but the recall does not specify a risk of injury or serious harm. Read more at govinfonow.com/recall/51376-noxbox-nitric-oxide-delivery-system-recall-button-errors-cause-system.
“NOXBOX Nitric Oxide Delivery System Recall: Button Errors Cause System Fault.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51376-noxbox-nitric-oxide-delivery-system-recall-button-errors-cause-system. Based on FDA recall #Z-0029-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0029-2026%22&limit=1).
NOXBOX LTD voluntarily recalled its NOxBOXi Nitric Oxide Delivery System (Model NOXBOX-I) due to an internal fault that may occur when users rapidly press buttons without waiting for system responses, the FDA announced on Sept. 9, 2025.
How to tell if you have it
Brand: NOXBOX
Product: NOxBOXi Nitric Oxide Delivery System
Model Numbers: NOXBOX-I, NOXBOXI (NBL), REQNOXBOXI (Linde)
UDI-DI: 05060541640009
All serial numbers
Quantity: 1667 units
Distribution: Domestic: TN
The hazard
The recall addresses an unexpected internal fault or system diagnostic error resulting from a rapid succession of button selections made to the user interface without waiting for the device to respond. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show NOXBOX LTD has issued five other recalls since May 3, 2023. Other recent recalls of similar products include Datex-Ohmeda Aisys Anesthesia System Recall (July 30, 2026), Datex-Ohmeda Aisys CS2 Anesthesia System Recall (July 30, 2026), and Baxter Novum IQ Syringe Pump Recall (Aug. 11, 2026).
How to tell if you have this one
Check for model numbers NOXBOX-I, NOXBOXI (NBL), or REQNOXBOXI (Linde) on the device. All serial numbers are affected, so verify the device's serial number against the list provided.
Brand
NOXBOX
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify the model number on your NOxBOXi Nitric Oxide Delivery System to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in Tennessee.
Listed by the agency
Not listed
FDA distribution: “Domestic: TN;” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Tennessee.
Recall timeline
FDA published this recall 36 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0029-2026 (September 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0029-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.