NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Reason for recall
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
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 System. Model Number:NOXBOX-IUDI-DI 05060541640009.Model Number400 affected lotsNI100825NI100833NI100839NI100840NI100841NI100847NI100848NI100849
+392 more
NI100850NI100851NI100852NI100855NI100858NI100859NI100861NI100862NI100865NI100866NI100868NI100869NI100872NI100873NI100875NI100876NI100878NI100879NI100880NI100881NI100882NI100883NI100884NI100885NI100886NI100887NI100888NI100895NI100932NI100935NI100942NI100948NI100949NI100953NI100961NI100975NI100976NI100978NI100980NI100983NI100985NI100986NI100987NI100989NI100990NI100991NI100993NI100994NI100996NI100997NI100999NI101001NI101002NI101003NI101004NI101005NI101006NI101008NI101009NI101010NI101011NI101012NI101013NI101014NI101015NI101017NI101018NI101019NI101024NI101026NI101028NI101029NI101030NI101031NI101033NI101034NI101035NI101038NI101039NI101041NI101042NI101044NI101048NI101049NI101052NI101057NI101059NI101060NI101061NI101063NI101065NI101067NI101069NI101071NI101072NI101073NI101077NI101079NI101080NI101081NI101083NI101084NI101086NI101088NI101089NI101090NI101091NI101092NI101093NI101094NI101095NI101099NI101100NI101101NI101105NI101106NI101107NI101108NI101109NI101110NI101111NI101112NI101113NI101114NI101115NI101116NI101117NI101125NI101130NI101131NI101132NI101133NI101134NI101135NI101136NI101137NI101138NI101141NI101142NI101144NI101145NI101146NI101147NI101148NI101149NI101150NI101151NI101153NI101154NI101155NI101156NI101158NI101159NI101160NI101161NI101162NI101163NI101164NI101165NI101167NI101168NI101170NI101173NI101174NI101175NI101176NI101177NI101178NI101179NI101180NI101181NI101182NI101183NI101184NI101190NI101191NI101192NI101199NI101202NI101204NI101205NI101207NI101208NI101209NI101211NI101212NI101213NI101214NI101215NI101216NI101217NI101218NI101219NI101220NI101221NI101222NI101223NI101224NI101225NI101227NI101228NI101229NI101230NI101231NI101232NI101233NI101234NI101236NI101237NI101241NI101243NI101244NI101245NI101246NI101249NI101250NI101251NI101252NI101253NI101254NI101255NI101256NI101257NI101258NI101259NI101263NI101264NI101265NI101266NI101268NI101270NI101271NI101273NI101278NI101282NI101284NI101285NI101286NI101287NI101288NI101289NI101292NI101294NI101295NI101297NI101298NI101299NI101300NI101301NI101303NI101305NI101307NI101308NI101309NI101313NI101314NI101317NI101321NI101322NI101323NI101324NI101326NI101327NI101328NI101329NI101330NI101331NI101333NI101335NI101336NI101337NI101338NI101340NI101342NI101344NI101346NI101347NI101349NI101350NI101351NI101353NI101354NI101355NI101356NI101357NI101359NI101360NI101361NI101368NI101372NI101373NI101376NI101377NI101379NI101380NI101381NI101384NI101386NI101387NI101388NI101390NI101392NI101393NI101394NI101395NI101396NI101402NI101404NI101405NI101406NI101407NI101408NI101409NI101410NI101411NI101412NI101413NI101414NI101415NI101416NI101423NI101425NI101426NI101428NI101429NI101430NI101431NI101432NI101433NI101434NI101435NI101436NI101437NI101439NI101441NI101442NI101443NI101444NI101446NI101448NI101449NI101451NI101452NI101454NI101456NI101457NI101459NI101460NI101461NI101462NI101463NI101464NI101467NI101468NI101469NI101472NI101473NI101474NI101475NI101478NI101479NI101482NI101483NI101484NI101485NI101486NI101487NI101489NI101490NI101491NI101492NI101496NI101505NI101506NI101508NI101509NI101512NI101514NI101515NI101516NI101520NI101521NI101522NI101524NI101525NI101526NI101527NI101529NI101530NI101532NI101533NI101540
What the firm is doing
On about 08/31/2026 NOXBOX initially notified its single distributor of the recall via emailed URGENT MEDCIAL DEVICE CORRECTION letter. The letter instructed distributors to examine inventory for affected units, complete and return the provided Distributor Response Form, arrange for the replacement of affected oxygen sensors, perform all preventive maintenance checks on NOxBOXi devices prior to distribution of units, ensure all applicable personnel are notified within the organization, notify all customers who have received affected units. Device users were instructed to examine inventory for affected units, complete and return the provided Customer Response Form to their respective distributor, ensure all applicable personnel or organizations (if units were transferred) are notified within the organization, and ensure personnel using the device are made aware. NOxBOX is working with the oxygen sensor manufacturer to obtain replacement sensors for all affected devices and will coordinate with distributors to implement sensor replacement activities. As such, NOxBOX is asking distributors and customers to promptly return the Response Forms as instructed on the form to confirm the number devices still in service and the number of sensor replacements required.
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-3306-2026
- 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 · K231823The device's official FDA premarket clearance record
- FDA 510(k) clearance · K233251The 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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