Quick Facts at a Glance
- Recall Date
- July 19, 2023
- Hazard Level
- HIGH
- Brand
- NOXBOX
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- NOXBOX
- Product type
- Nitric Oxide Delivery System
- Model numbers
- NOXBOXI, NI102738, NI103021, NI103146, NI101560, NI101059, NI102922, NI101034 +11 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 19, 2023
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Replacement of the internal Sample Pump due to high failure rates.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact NOXBOX LTD or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The NOxBOXi is a nitric oxide delivery system used in medical settings to deliver controlled nitric oxide therapy. It is used by healthcare providers with specialized protocols.
Why This Is Dangerous
An internal Sample Pump with high failure rates can compromise device performance and reliability in delivering nitric oxide.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Clinicians may need to switch to an alternative device or remediation plan, potentially delaying therapy.
Practical Guidance
How to identify if yours is affected
- Review model NOXBOXI and serial numbers listed (e.g., NI102738, NI103021, NI103146, NI101560, NI101059).
- Check UDI 05060541640009 on the device label.
- Confirm distribution in the U.S. with Tennessee notes.
Where to find product info
UDI label and device paperwork; manufacturer recall communications sent by email.
What timeline to expect
Remedy requires manufacturer-guided remediation; timeline not specified in data.
If the manufacturer is unresponsive
- Document all attempts to contact NOXBOX LTD.
- File a report with the FDA if remediation is inadequate.
How to prevent similar issues
- Verify serial numbers before deployment of any NOxBOXi device.
- Maintain updated contact information with the manufacturer for recall notices.
Documentation advice
Keep recall notice, emails, serial numbers, model numbers, and any remediation communications.
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Product Details
Model No. NOXBOXI. UDI: 05060541640009. Serial numbers include NI102738, NI103021, NI103146, NI101560, NI101059, NI102922, NI101034, NI102152, NI102854, NI101289, NI102957, NI102642, NI101960, NI102163, NI101717, NI102928, NI101146, NI101209. Quantity recalled: 1,667 units. Sold and distributed nationwide in the US, with distribution in Tennessee. Recall date: 2023-07-19. Status: ACTIVE. Hazard level: HIGH.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model No. NOXBOXI with UDI 05060541640009
- US nationwide distribution with Tennessee noted
- Recall date 2023-07-19; status ACTIVE
- Hazard level HIGH
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Safety Guide
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