NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System.
Reason for recall
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- NOxBOXi Nitric Oxide Delivery SystemUDIUDI-DI 05060541640009.400 affected lotsNM100825NM100833NM100839NM100840NM100841NM100847NM100848NM100849
+392 more
NM100850NM100851NM100852NM100855NM100858NM100859NM100861NM100862NM100865NM100866NM100868NM100869NM100872NM100873NM100875NM100876NM100878NM100879NM100880NM100881NM100882NM100883NM100884NM100885NM100886NM100887NM100888NM100895NM100932NM100935NM100942NM100948NM100949NM100953NM100961NM100975NM100976NM100978NM100980NM100983NM100985NM100986NM100987NM100989NM100990NM100991NM100993NM100994NM100996NM100997NM100999NM101001NM101002NM101003NM101004NM101005NM101006NM101008NM101009NM101010NM101011NM101012NM101013NM101014NM101015NM101017NM101018NM101019NM101024NM101026NM101028NM101029NM101030NM101031NM101033NM101034NM101035NM101038NM101039NM101041NM101042NM101044NM101048NM101049NM101052NM101057NM101059NM101060NM101061NM101063NM101065NM101067NM101069NM101071NM101072NM101073NM101077NM101079NM101080NM101081NM101083NM101084NM101086NM101088NM101089NM101090NM101091NM101092NM101093NM101094NM101095NM101099NM101100NM101101NM101105NM101106NM101107NM101108NM101109NM101110NM101111NM101112NM101113NM101114NM101115NM101116NM101117NM101125NM101130NM101131NM101132NM101133NM101134NM101135NM101136NM101137NM101138NM101141NM101142NM101144NM101145NM101146NM101147NM101148NM101149NM101150NM101151NM101153NM101154NM101155NM101156NM101158NM101159NM101160NM101161NM101162NM101163NM101164NM101165NM101167NM101168NM101170NM101173NM101174NM101175NM101176NM101177NM101178NM101179NM101180NM101181NM101182NM101183NM101184NM101190NM101191NM101192NM101199NM101202NM101204NM101205NM101207NM101208NM101209NM101211NM101212NM101213NM101214NM101215NM101216NM101217NM101218NM101219NM101220NM101221NM101222NM101223NM101224NM101225NM101227NM101228NM101229NM101230NM101231NM101232NM101233NM101234NM101236NM101237NM101241NM101243NM101244NM101245NM101246NM101249NM101250NM101251NM101252NM101253NM101254NM101255NM101256NM101257NM101258NM101259NM101263NM101264NM101265NM101266NM101268NM101270NM101271NM101273NM101278NM101282NM101284NM101285NM101286NM101287NM101288NM101289NM101292NM101294NM101295NM101297NM101298NM101299NM101300NM101301NM101303NM101305NM101307NM101308NM101309NM101313NM101314NM101317NM101321NM101322NM101323NM101324NM101326NM101327NM101328NM101329NM101330NM101331NM101333NM101335NM101336NM101337NM101338NM101340NM101342NM101344NM101346NM101347NM101349NM101350NM101351NM101353NM101354NM101355NM101356NM101357NM101359NM101360NM101361NM101368NM101372NM101373NM101376NM101377NM101379NM101380NM101381NM101384NM101386NM101387NM101388NM101390NM101392NM101393NM101394NM101395NM101396NM101402NM101404NM101405NM101406NM101407NM101408NM101409NM101410NM101411NM101412NM101413NM101414NM101415NM101416NM101423NM101425NM101426NM101428NM101429NM101430NM101431NM101432NM101433NM101434NM101435NM101436NM101437NM101439NM101441NM101442NM101443NM101444NM101446NM101448NM101449NM101451NM101452NM101454NM101456NM101457NM101459NM101460NM101461NM101462NM101463NM101464NM101467NM101468NM101469NM101472NM101473NM101474NM101475NM101478NM101479NM101482NM101483NM101484NM101485NM101486NM101487NM101489NM101490NM101491NM101492NM101496NM101505NM101506NM101508NM101509NM101512NM101514NM101515NM101516NM101520NM101521NM101522NM101524NM101525NM101526NM101527NM101529NM101530NM101532NM101533NM101540
What the firm is doing
NOxBOX notified its single US distributor on about 08/19/2026 via emailed "URGENT MEDICAL DEVICE CORRECTION" letter. Consignees were informed of the issue of potential oxygen leaks within the NOxMixer module of the NOxBOXi device due to failure of the tubing or tubing connection. This may lead to interruption in nitric oxide therapy, which could lead to oxygen desaturation and necessitate medical intervention. Distributors were instructed to examine inventory for affected units, complete and return the Distributor Response Form provided and NOxBOX will provide work instructions and material to complete the NOxMixer repairs. Before distributing any affected devices, perform all preventive maintenance checks on NOxBOXi devices. Those that have passed all preventive maintenance checks can continue to be distributed with a copy of this notice. Devices that do not pass must be quarantined until remediated. Distributors were also instructed to notify all affected customers and applicable personnel. Users of the device were instructed to examine inventory for affected, complete and return the Customer Response form provided, and provide the notification to all those who need to be made aware within the organization or to any organization where the potentially affected devices have been transferred or for which this action has an impact. Customers should ensure that all personnel using the device are provided with a copy of the recommendations in Attachment D and post them near the device. NOxBOX has developed a replacement for the tubing and tubing connection and will be working with distributors to implement for their affected devices. Further details will be provided to distributors to ensure all upgrades are successfully completed. In addition, NOxBOX is implementing an update to the NOxBOXi + NOxMixer Service Manual to include inspection of the NOxMixer internal oxygen tubing and tubing connection for replacement as part of the preventative maintenance (PM) sche
DistributionShow detailsHide
US Nationwide distribution in the state of Georgia.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3165-2026
- FDA 510(k) clearance · K171696The device's official FDA premarket clearance record
- FDA 510(k) clearance · K201339The device's official FDA premarket clearance record
- FDA 510(k) clearance · K220898The device's official FDA premarket clearance record
- FDA 510(k) clearance · K233251The device's official FDA premarket clearance record
- FDA 510(k) clearance · K231823The device's official FDA premarket clearance record
- FDA device classification · MRNOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5165The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find NOXBOX LTDSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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