CLASS II · ModerateFDA

NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System.

📅 Aug 19, 2026 · 📍 Nationwide

Recalling company: NOXBOX LTD
Product: NOxBOXi Nitric Oxide Delivery System.
Reason: Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
Classification: Class II – may cause temporary or medically reversible health consequences
Recall date: Aug 19, 2026
Reported: Sep 23, 2026
Distribution: US Nationwide distribution in the state of Georgia.
Status: Ongoing
Quantity: 1,547 units
Lot / codes: UDI-DI 05060541640009. Identification Number (Serial Number): NM100825 (NI100825), NM100833 (NI100833), NM100839 (NI100839), NM100840 (NI100840), NM100841 (NI100841), NM100847 (NI100847), NM100848 (NI100848), NM100849 (NI100849), NM100850 (NI100850), NM100851 (NI100851), NM100852 (NI100852), NM100855 (NI100855), NM100858 (NI100858), NM100859 (NI100859), NM100861 (NI100861), NM100862 (NI100862), NM100865 (NI100865), NM100866 (NI100866), NM100868 (NI100868), NM100869 (NI100869), NM100872 (NI100872), NM100873 (NI100873), NM100875 (NI100875), NM100876 (NI100876), NM100878 (NI100878), NM100879 (NI100879), NM100880 (NI100880), NM100881 (NI100881), NM100882 (NI100882), NM100883 (NI100883), NM100884 (NI100884), NM100885 (NI100885), NM100886 (NI100886), NM100887 (NI100887), NM100888 (NI100888), NM100895 (NI100895), NM100932 (NI100932), NM100935 (NI100935), NM100942 (NI100942), NM100948 (NI100948), NM100949 (NI100949), NM100953 (NI100953), NM100961 (NI100961), NM100975 (NI100975), NM100976 (NI100976), NM100978 (NI100978), NM100980 (NI100980), NM100983 (NI100983), NM100985 (NI100985), NM100986 (NI100986), NM100987 (NI100987), NM100989 (NI100989), NM100990 (NI100990), NM100991 (NI100991), NM100993 (NI100993), NM100994 (NI100994), NM100996 (NI100996), NM100997 (NI100997), NM100999 (NI100999), NM101001 (NI101001), NM101002 (NI101002), NM101003 (NI101003), NM101004 (NI101004), NM101005 (NI101005), NM101006 (NI101006), NM101008 (NI101008), NM101009 (NI101009), NM101010 (NI101010), NM101011 (
Company location: Sittingbourne, N/A
Recall type: Voluntary: Firm initiated
Recall number: Z-3165-2026
Agency: U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3165-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.