Recall archive / FDA device enforcement
NOxBOXi Nitric Oxide Delivery System. — FDA record Z-3165-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 19, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- NOXBOX LTD
- Quantity
- 1,547 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3165-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 (NI101011), NM101012 (NI101012), NM101013 (NI101013), NM101014 (NI101014), NM101015 (NI101015), NM101017 (NI101017), NM101018 (NI101018), NM101019 (NI101019), NM101024 (NI101024), NM101026 (NI101026), NM101028 (NI101028), NM101029 (NI101029), NM101030 (NI101030), NM101031 (NI101031), NM101033 (NI101033), NM101034 (NI101034), NM101035 (NI101035), NM101038 (NI101038), NM101039 (NI101039), NM101041 (NI101041), NM101042 (NI101042), NM101044 (NI101044), NM101048 (NI101048), NM101049 (NI101049), NM101052 (NI101052), NM101057 (NI101057), NM101059 (NI101059), NM101060 (NI101060), NM101061 (NI101061), NM101063 (NI101063), NM101065 (NI101065), NM101067 (NI101067), NM101069 (NI101069), NM101071 (NI101071), NM101072 (NI101072), NM101073 (NI101073), NM101077 (NI101077), NM101079 (NI101079), NM101080 (NI101080), NM101081 (NI101081), NM101083 (NI101083), NM101084 (NI101084), NM101086 (NI101086), NM101088 (NI101088), NM101089 (NI101089), NM101090 (NI101090), NM101091 (NI101091), NM101092 (NI101092), NM101093 (NI101093), NM101094 (NI101094), NM101095 (NI101095), NM101099 (NI101099), NM101100 (NI101100), NM101101 (NI101101), NM101105 (NI101105), NM101106 (NI101106), NM101107 (NI101107), NM101108 (NI101108), NM101109 (NI101109), NM101110 (NI101110), NM101111 (NI101111), NM101112 (NI101112), NM101113 (NI101113), NM101114 (NI101114), NM101115 (NI101115), NM101116 (NI101116), NM101117 (NI101117), NM101125 (NI101125), NM101130 (NI101130), NM101131 (NI101131), NM101132 (NI101132), NM101133 (NI101133), NM101134 (NI101134), NM101135 (NI101135), NM101136 (NI101136), NM101137 (NI101137), NM101138 (NI101138), NM101141 (NI101141), NM101142 (NI101142), NM101144 (NI101144), NM101145 (NI101145), NM101146 (NI101146), NM101147 (NI101147), NM101148 (NI101148), NM101149 (NI101149), NM101150 (NI101150), NM101151 (NI101151), NM101153 (NI101153), NM101154 (NI101154), NM101155 (NI101155), NM101156 (NI101156), NM101158 (NI101158), NM101159 (NI101159), NM101160 (NI101160), NM101161 (NI101161), NM101162 (NI101162), NM101163 (NI101163), NM101164 (NI101164), NM101165 (NI101165), NM101167 (NI101167), NM101168 (NI101168), NM101170 (NI101170), NM101173 (NI101173), NM101174 (NI101174), NM101175 (NI101175), NM101176 (NI101176), NM101177 (NI101177), NM101178 (NI101178), NM101179 (NI101179), NM101180 (NI101180), NM101181 (NI101181), NM101182 (NI101182), NM101183 (NI101183), NM101184 (NI101184), NM101190 (NI101190), NM101191 (NI101191), NM101192 (NI101192), NM101199 (NI101199), NM101202 (NI101202), NM101204 (NI101204), NM101205 (NI101205), NM101207 (NI101207), NM101208 (NI101208), NM101209 (NI101209), NM101211 (NI101211), NM101212 (NI101212), NM101213 (NI101213), NM101214 (NI101214), NM101215 (NI101215), NM101216 (NI101216), NM101217 (NI101217), NM101218 (NI101218), NM101219 (NI101219), NM101220 (NI101220), NM101221 (NI101221), NM101222 (NI101222), NM101223 (NI101223), NM101224 (NI101224), NM101225 (NI101225), NM101227 (NI101227), NM101228 (NI101228), NM101229 (NI101229), NM101230 (NI101230), NM101231 (NI101231), NM101232 (NI101232), NM101233 (NI101233), NM101234 (NI101234), NM101236 (NI101236), NM101237 (NI101237), NM101241 (NI101241), NM101243 (NI101243), NM101244 (NI101244), NM101245 (NI101245), NM101246 (NI101246), NM101249 (NI101249), NM101250 (NI101250), NM101251 (NI101251), NM101252 (NI101252), NM101253 (NI101253), NM101254 (NI101254), NM101255 (NI101255), NM101256 (NI101256), NM101257 (NI101257), NM101258 (NI101258), NM101259 (NI101259), NM101263 (NI101263), NM101264 (NI101264), NM101265 (NI101265), NM101266 (NI101266), NM101268 (NI101268), NM101270 (NI101270), NM101271 (NI101271), NM101273 (NI101273), NM101278 (NI101278), NM101282 (NI101282), NM101284 (NI101284), NM101285 (NI101285), NM101286 (NI101286), NM101287 (NI101287), NM101288 (NI101288), NM101289 (NI101289), NM101292 (NI101292), NM101294 (NI101294), NM101295 (NI101295), NM101297 (NI101297), NM101298 (NI101298), NM101299 (NI101299), NM101300 (NI101300), NM101301 (NI101301), NM101303 (NI101303), NM101305 (NI101305), NM101307 (NI101307), NM101308 (NI101308), NM101309 (NI101309), NM101313 (NI101313), NM101314 (NI101314), NM101317 (NI101317), NM101321 (NI101321), NM101322 (NI101322), NM101323 (NI101323), NM101324 (NI101324), NM101326 (NI101326), NM101327 (NI101327), NM101328 (NI101328), NM101329 (NI101329), NM101330 (NI101330), NM101331 (NI101331), NM101333 (NI101333), NM101335 (NI101335), NM101336 (NI101336), NM101337 (NI101337), NM101338 (NI101338), NM101340 (NI101340), NM101342 (NI101342), NM101344 (NI101344), NM101346 (NI101346), NM101347 (NI101347), NM101349 (NI101349), NM101350 (NI101350), NM101351 (NI101351), NM101353 (NI101353), NM101354 (NI101354), NM101355 (NI101355), NM101356 (NI101356), NM101357 (NI101357), NM101359 (NI101359), NM101360 (NI101360), NM101361 (NI101361), NM101368 (NI101368), NM101372 (NI101372), NM101373 (NI101373), NM101376 (NI101376), NM101377 (NI101377), NM101379 (NI101379), NM101380 (NI101380), NM101381 (NI101381), NM101384 (NI101384), NM101386 (NI101386), NM101387 (NI101387), NM101388 (NI101388), NM101390 (NI101390), NM101392 (NI101392), NM101393 (NI101393), NM101394 (NI101394), NM101395 (NI101395), NM101396 (NI101396), NM101402 (NI101402), NM101404 (NI101404), NM101405 (NI101405), NM101406 (NI101406), NM101407 (NI101407), NM101408 (NI101408), NM101409 (NI101409), NM101410 (NI101410), NM101411 (NI101411), NM101412 (NI101412), NM101413 (NI101413), NM101414 (NI101414), NM101415 (NI101415), NM101416 (NI101416), NM101423 (NI101423), NM101425 (NI101425), NM101426 (NI101426), NM101428 (NI101428), NM101429 (NI101429), NM101430 (NI101430), NM101431 (NI101431), NM101432 (NI101432), NM101433 (NI101433), NM101434 (NI101434), NM101435 (NI101435), NM101436 (NI101436), NM101437 (NI101437), NM101439 (NI101439), NM101441 (NI101441), NM101442 (NI101442), NM101443 (NI101443), NM101444 (NI101444), NM101446 (NI101446), NM101448 (NI101448), NM101449 (NI101449), NM101451 (NI101451), NM101452 (NI101452), NM101454 (NI101454), NM101456 (NI101456), NM101457 (NI101457), NM101459 (NI101459), NM101460 (NI101460), NM101461 (NI101461), NM101462 (NI101462), NM101463 (NI101463), NM101464 (NI101464), NM101467 (NI101467), NM101468 (NI101468), NM101469 (NI101469), NM101472 (NI101472), NM101473 (NI101473), NM101474 (NI101474), NM101475 (NI101475), NM101478 (NI101478), NM101479 (NI101479), NM101482 (NI101482), NM101483 (NI101483), NM101484 (NI101484), NM101485 (NI101485), NM101486 (NI101486), NM101487 (NI101487), NM101489 (NI101489), NM101490 (NI101490), NM101491 (NI101491), NM101492 (NI101492), NM101496 (NI101496), NM101505 (NI101505), NM101506 (NI101506), NM101508 (NI101508), NM101509 (NI101509), NM101512 (NI101512), NM101514 (NI101514), NM101515 (NI101515), NM101516 (NI101516), NM101520 (NI101520), NM101521 (NI101521), NM101522 (NI101522), NM101524 (NI101524), NM101525 (NI101525), NM101526 (NI101526), NM101527 (NI101527), NM101529 (NI101529), NM101530 (NI101530), NM101532 (NI101532), NM101533 (NI101533), NM101540 (NI101540), NM101550 (NI101550), NM101551 (NI101551), NM101552 (NI101552), NM101553 (NI101553), NM101554 (NI101554), NM101557 (NI101557), NM101560 (NI101560), NM101563 (NI101563), NM101565 (NI101565), NM101566 (NI101566), NM101569 (NI101569), NM101570 (NI101570), NM101572 (NI101572), NM101573 (NI101573), NM101574 (NI101574), NM101575 (NI101575), NM101576 (NI101576), NM101577 (NI101577), NM101578 (NI101578), NM101579 (NI101579), NM101581 (NI101581), NM101584 (NI101584), NM101585 (NI101585), NM101588 (NI101588), NM101590 (NI101590), NM101591 (NI101591), NM101592 (NI101592), NM101593 (NI101593), NM101594 (NI101594), NM101595 (NI101595), NM101596 (NI101596), NM101597 (NI101597), NM101598 (NI101598), NM101599 (NI101599), NM101600 (NI101600), NM101601 (NI101601), NM101602 (NI101602), NM101604 (NI101604), NM101605 (NI101605), NM101606 (NI101606), NM101607 (NI101607), NM101608 (NI101608), NM101609 (NI101609), NM101610 (NI101610), NM101611 (NI101611), NM101612 (NI101612), NM101613 (NI101613), NM101614 (NI101614), NM101615 (NI101615), NM101616 (NI101616), NM101617 (NI101617), NM101620 (NI101620), NM101622 (NI101622), NM101623 (NI101623), NM101624 (NI101624), NM101625 (NI101625), NM101626 (NI101626), NM101627 (NI101627), NM101628 (NI101628), NM101629 (NI101629), NM101635 (NI101635), NM101636 (NI101636), NM101638 (NI101638), NM101639 (NI101639), NM101640 (NI101640), NM101641 (NI101641), NM101643 (NI101643), NM101644 (NI101644), NM101645 (NI101645), NM101651 (NI101651), NM101654 (NI101654), NM101655 (NI101655), NM101656 (NI101656), NM101657 (NI101657), NM101658 (NI101658), NM101659 (NI101659), NM101660 (NI101660), NM101662 (NI101662), NM101664 (NI101664), NM101665 (NI101665), NM101666 (NI101666), NM101667 (NI101667), NM101668 (NI101668), NM101669 (NI101669), NM101670 (NI101670), NM101671 (NI101671), NM101672 (NI101672), NM101674 (NI101674), NM101675 (NI101675), NM101676 (NI101676), NM101677 (NI101677), NM101678 (NI101678), NM101679 (NI101679), NM101680 (NI101680), NM101681 (NI101681), NM101682 (NI101682), NM101683 (NI101683), NM101684 (NI101684), NM101685 (NI101685), NM101686 (NI101686), NM101687 (NI101687), NM101688 (NI101688), NM101689 (NI101689), NM101690 (NI101690), NM101691 (NI101691), NM101692 (NI101692), NM101693 (NI101693), NM101694 (NI101694), NM101695 (NI101695), NM101696 (NI101696), NM101697 (NI101697), NM101699 (NI101699), NM101700 (NI101700), NM101703 (NI101703), NM101704 (NI101704), NM101705 (NI101705), NM101706 (NI101706), NM101707 (NI101707), NM101708 (NI101708), NM101709 (NI101709), NM101710 (NI101710), NM101711 (NI101711), NM101712 (NI101712), NM101713 (NI101713), NM101714 (NI101714), NM101715 (NI101715), NM101716 (NI101716), NM101717 (NI101717), NM101718 (NI101718), NM101719 (NI101719), NM101720 (NI101720), NM101721 (NI101721), NM101722 (NI101722), NM101723 (NI101723), NM101724 (NI101724), NM101726 (NI101726), NM101727 (NI101727), NM101729 (NI101729), NM101731 (NI101731), NM101732 (NI101732), NM101733 (NI101733), NM101735 (NI101735), NM101736 (NI101736), NM101737 (NI101737), NM101739 (NI101739), NM101740 (NI101740), NM101742 (NI101742), NM101743 (NI101743), NM101744 (NI101744), NM101746 (NI101746), NM101747 (NI101747), NM101748 (NI101748), NM101749 (NI101749), NM101750 (NI101750), NM101751 (NI101751), NM101753 (NI101753), NM101756 (NI101756), NM101759 (NI101759), NM101760 (NI101760), NM101761 (NI101761), NM101763 (NI101763), NM101765 (NI101765), NM101766 (NI101766), NM101767 (NI101767), NM101768 (NI101768), NM101769 (NI101769), NM101770 (NI101770), NM101771 (NI101771), NM10177... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the state of Georgia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 23, 2026
- Recall initiation date
- Aug 19, 2026
- Center classification date
- Sep 15, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.