Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
NOxBOXi Nitric Oxide Delivery System Recalled by NOXBOX LTD Due to Device may experience malfunctions due to misalignment of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact NOXBOX LTD directly.
Affected Products
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Quantity: 548 (US); 208 (OUS)
Why Was This Recalled?
Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About NOXBOX LTD
NOXBOX LTD has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report