Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X15B, RU2200X15B

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 606959052017, 606959056497, 606959061033, 606959052321, 606959058613, 606959058620, 606959058644, 606959058668, 606959058675, 606959058682, 606959058705, 606959058798, 606959052000. UDI-DI, Model number: Serial numbers 606959052017, DS2200X11B: H27990931E388, H27990933C09A, H27990934B425, H279909369737, H28068115E37D, H28068117C06F, H28086487E130, H280912810EBA, H28091329255E, H280914614273, H28091549A757, H28091634DEDE, H28091674B9BE, H280918082EC1, H280918779B3E, H28091945C898, H28092332A798, H2809235587F7, H28092419A6FE, H280924344EAB, H280924473138, H28092465219A, H280924717E66, H28092478E3A7, H28092499683E, H2809251427C7, H280925341477, H280925522591, H280925631E70, H28092614C8A3, H28096497F3AC, H280964991AD2, H280965000AD7, H280965011B5E, H2809650229C5, H28096503384C, H280965044CF3, H280965055D7A, H280965066FE1, H280965077E68, H28270803E547, H28270834BB90, H28270854EF40, H28270873A84F, H282708832B87, H28270893325F, H28270902AE12, H28270921AF39, H282709382B20, H282709468F56, H28270960D9D0, H28270971D181, H282710044B81, H282710230C8E, H282710274AAA, H2827103027CD, H2827103642FB, H2827104249D7, H282710516294, H2827105707A2, H28271078CCE5, H28271082E077, 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H291564390B6C, H291564906BDD, H291565169AF7, H29156565E564, H29156577DFAE, H291565903101, H291566212B44, H29157205210A, H291572106F7F, H291572135DE4, H291572204517, H29157223778C, H291572262021, H2915722731A8, H291572350B62, H29157243235C, H291572489D8F, H291572544E3B, H291572577CA0, H291572620165, H291572756C02, H29157280B867, H29157288342F, H29157295F612, H291573002C7B, H2915730758C4, H2915731216B1, H291573165095, H291573210E42, H2915732459EF, H29167986E93B, H291680024F38, H291680466E7C, H2916807313B9, H29168094FD16, H291681131DB5, H29168119B2EF, H291687864BD9, H29168842EE9A, H29168847B937, H291688495049, H29168851C5D9, H29168852F742, H291688549274, H2916885583FD, H29168857A0EF, H291688594991, H29168861EFB1, H29168865A995, H2916886963F9, H29168871F669, H29168872C4F2, H29168874A1C4, H29168886011E, H291688916C79, H29168933E8C7, H29168936BF6A, H29168937AEE3, H29168939479D, H2916894186DD, H29168942B446, H291689481B1C, H29168952AD9E, H29168954C8A8, H29168957FA33, H2916896287F6, H29168963967F, H29168965F349, H2916896828AC, H29168974FB18, H29168977C983, H291689830C6F, H291689865BC2, H291689874A4B, H29168992043E, H291689946108, H2916904451D5, H29169047634E, H291690500E29, H29169054480D, H291690577A96, H2916905993E8, H291690730F02, H29169078B1D1, H291690829D43, H29169084F875, H29169087CAEE, H291690892390, H29171285B2D8, H29171288693D, H29171290FCAD, H29171294BA89, H29171296999B, H2917129870E5, H29171299616C, H29171308FD21, H2917131068B1, H291713135A2A, H291713160D87, H291713171C0E, H2917132042D9, H2917132261CB, H2917132627EF, H29171333699A, H2917134541A4, H291713489A41, H291713511E58, H291713533D4A, H291713566AE7, H291713588399, H291713613430, H291713631722, H291713982A39, H2917140960AD, H29171411F53D, H29171412C7A6, H29171422EDCE, H29171423FC47, H29171429531D, H29171431C68D, H29171443A897, H291714591E15, H29171469347D, H29171470B064, H29171471A1ED, H29171474F640, H291714812225, H291714830137, H29171505F01D, H29171510BE68, H291715129D7A, H29171534CBFC, H29171545977D, H29171550D908, H2917156787DF, H291715916121, H2917160048D4, H291716051F79, H2917162349FF, H29171628F72C, H2917165127E5, H2917165304F7, H29171656535A, H29171658BA24, H29171659ABAD, H291716601C04, H291716610D8D, H291716623F16, H291716645A20, H291717001208, H291717100BD0, H291717144DF4, H291717188798, H291717199611, H2917172021B8, H291717213031, H2917172202AA, H29171726448E, H291717330AFB, H291717374CDF, H29171738B428, H29171739A5A1, H2917174701D7, H291717637443, H291717736D9B, H29171793F78B, H291718072C70, H291718502677, H2917185571DA, H291718600C1F, H29171871044E, H291718818786, H2917780544F8, H2917784165BC, H291778461103, H29177849E9F4, H291778553A40, H291800974BED, H29180160E646, H291801843A72, H291801971131, H29182545D84C, H29182577D136, H291825846065, H2918259479BD, H2918260224F7, H291826101E3D, H291826176A82, H291826247271, H291826320E9F, H291826424397, H29182647143A, H291826525A4F, H291826650498, H2918267269FF, H29182679D72C, H291852164F4B, H291852323ADF, H291852642151, H29185288712D, H291853161597, H29185357637E, H291854086934, H29185410FCA4, H2918582341F4, H291860093E11, H29186015EDA5, H2918601927C9, H291913571AD6, H291913604401, H291913615588, H291913626713, H29191363769A, H291913640225, H291913662137, H2919136730BE, H29191368C849, H29191369D9C0, H29191378D191, H29191379C018, H29191380DE11, H29191381CF98, H29191382FD03, H2919139481ED, H29191397B376, H291913995A08, H29191405CB79, H29191406F9E2, H29191408109C, H291914090115, H29191410850C, H29191413B797, H29191414C328, H291914180944, H29191420AF64, H29191421BEED, H291914228C76, H291914239DFF, H29191424E940, H29191426CA52, H2919143295AE, H291914338427, H29191
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Respironics, Inc.
Reason for Recall:
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X15B, RU2200X15B

Product Codes/Lot Numbers:

UDI-DI: 606959052017, 606959056497, 606959061033, 606959052321, 606959058613, 606959058620, 606959058644, 606959058668, 606959058675, 606959058682, 606959058705, 606959058798, 606959052000. UDI-DI, Model number: Serial numbers 606959052017, DS2200X11B: H27990931E388, H27990933C09A, H27990934B425, H279909369737, H28068115E37D, H28068117C06F, H28086487E130, H280912810EBA, H28091329255E, H280914614273, H28091549A757, H28091634DEDE, H28091674B9BE, H280918082EC1, H280918779B3E, H28091945C898, H28092332A798, H2809235587F7, H28092419A6FE, H280924344EAB, H280924473138, H28092465219A, H280924717E66, H28092478E3A7, H28092499683E, H2809251427C7, H280925341477, H280925522591, H280925631E70, H28092614C8A3, H28096497F3AC, H280964991AD2, H280965000AD7, H280965011B5E, H2809650229C5, H28096503384C, H280965044CF3, H280965055D7A, H280965066FE1, H280965077E68, H28270803E547, H28270834BB90, H28270854EF40, H28270873A84F, H282708832B87, H28270893325F, H28270902AE12, H28270921AF39, H282709382B20, H282709468F56, H28270960D9D0, H28270971D181, H282710044B81, H282710230C8E, H282710274AAA, H2827103027CD, H2827103642FB, H2827104249D7, H282710516294, H2827105707A2, H28271078CCE5, H28271082E077, H282710895EA4, H282710958D10, H28271104115D, H2827110723C6, H282744145F6F, H282791971106, H2828022698DC, H283571110611, H28357128B1B8, H28357134620C, H283833769D5E, H283833778CD7, H283833787420, H283833807BA0, H283833843D84, H283834175402, H28383418ACF5, H28383419BD7C, H28383432301F, H283834332196, H2838343544A0, H2838343767B2, H283834389F45, H283834405E05, H283834427D17, H2838345047DD, H2838345264CF, H2838345622EB, H283834573362, H28383458CB95, H283834635F2E, H283834660883, H28383472577F, H28383478F825, H28383484B181, H28383491FFF4, H2840965179B3, H28409679C64B, H28409680D842, H28409683EAD9, H2840972439CA, H284097324524, H284097360300, H284097402B3E, H2840974319A5, H2840975032E6, H2840975474C2, H2840975657D0, H28409760188E, H284097667DB8, H284097744772, H28409780829E, H284098099B58, H284098198280, H284098203529, H28422934E694, H2842311158F0, H28426246D3C4, H28426257DB95, H284263382D6E, H2842646415BF, H284264650436, H2842646636AD, H284264740C67, H284264762F75, H284264773EFC, H28426478C60B, H28426480C98B, H284264859E26, H28426486ACBD, H2842648845C3, H28426491C1DA, H28426492F341, H28426493E2C8, H284264949677, H2842649587FE, H28426496B565, H28426497A4EC, H284264985C1B, H284264994D92, H284265005D97, H284265027E85, H284465362951, H2844654333F4, H2844655018B7, H284465567D81, H284465882487, H28446594F733, H296722202119, H3311009663E8, H33113033ECF8, H288916282C32, H2889206563A3, H336070827CA0, H338358141554, H3353772568DB, H33696423BEE7, H338247100E48, H33952123BF0F, H33952148550C, H277504071D3B, H277504598AFD, H2775061483C0, H27750906F3CD, H277511623B40, H29472115BBEE, H2954061040D7, H29540655701A, H2954070445F7, H295408909E0C, H295877717F43, H295881689F7A, H2958819090FA, H29588192B3E8, H29588195C757, H29591208D6E9, H28130975B6C8, H28274405573E, H28274559B936, H28277529D1F3, H2827753055EA, H282775336771, H282775350247, H2827753630DC, H282775467DD4, H2827755333A1, H28277556640C, H282775602B52, H28277570328A, H2827757657BC, H28277580B142, H28277586D474, H282775892C83, H28277591B913, H282775928B88, H28277597DC25, H28277607E459, H28277612AA2C, H28277621B2DF, H2827762391CD, H282776282F1E, H2838646666D4, H283954602D6B, H283955333B94, H28396414038A, H2841393282D5, H2867243437E9, H286998412942, H287150343C1A, H287624745FE6, H287624818B83, H28762491925B, H287624991E13, H287625011F9F, H2876251451EA, H287625198A0F, H287625247B82, H287625274919, H2876254178FF, H287625460C40, H28762548E53E, H287625534235, H2876257514B3, H28762585977B, H287625884C9E, H28762597ADB1, H28762630CB1A, H28762631DA93, H28762632E808, H28762636AE2C, H2876263956DB, H28762642A500, H28762644C036, H28762646E324, H28762652BCD8, H287651660BB0, H28767205BBE9, H28767227AB4B, H28767233F4B7, H287672518375, H287672629B86, H28794675DAB1, H28818011EE01, H2902840571DD, H29032098C9AB, H290328513B08, H29033189879D, H290332301190, H29033657529E, H290338353547, H29034112B977, H29034149791C, H290394301BE7, H2903944275FD, H290394562A01, H2903946357C4, H2903946711E0, H290394734E1C, H290394752B2A, H2903947619B1, H29039494A0B3, H290395017ADA, H290395603F83, H29039741A802, H29039780102B, H29039816E8C2, H290398392385, H29039841E2C5, H29039845A4E1, H29039852C986, H29039853D80F, H29039855BD39, H290398597755, H290398814B65, H29040791D1C5, H29041106B800, H2904111482CA, H290411159343, H29041116A1D8, H2904111848A6, H29041119592F, H29041120EE86, H29041122CD94, H29041123DC1D, H290411268BB0, H29041133C5C5, H29041134B17A, H29041147CEE9, H29041175C793, H2904120123DB, H290422257382, H290422434264, H29042273680C, H290423037FD8, H290423040B67, H29042309D082, H290423353086, H29042359AE3A, H290423667CA5, H290423698452, H29042421E37F, H29042466F0A0, H2904249762E1, H290425282462, H290425915D0B, H29042658860E, H2904268927FF, H29042730044A, H290428983FB5, H29042917535E, H290429441F7D, H290429463C6F, H29042969F728, H29043120D7F0, H290431820992, H290432022836, H290432203894, H290432417DCD, H29043571DBA0, H290435873D5E, H290435950794, H29043596350F, H290435972486, H290436024B57, H290436071CFA, H2904361614AB, H2904363370B6, H290436411EAC, H290436477B9A, H29043670254D, H290436746369, H29043696DA6B, H290437056534, H290437146D65, H2904372110A0, H290456165F31, H290456355E1A, H290456399476, H29055124D10A, H290551290AEF, H290571794D21, H2905754815A1, H29057561BBD0, H2906923976AB, H2906924394F9, H290693785A9E, H290693926FD4, H29069398C08E, H290694010652, H290694133C98, H290694177ABC, H2906942135E2, H2906942573C6, H29069426415D, H29069428A823, H290694312C3A, H290694321EA1, H290694330F28, H29071279FF57, H29071280E15E, H290712868468, H2907128795E1, H290712886D16, H29071293CA1D, H29071294BEA2, H290713007542, H290713025650, H290713043366, H2907130701FD, H29071498A217, H29071499B39E, H290810729EC0, H29082691C55F, H29082696B1E0, H29082698589E, H290826994917, H29082701489B, H290827050EBF, H29082708D55A, H290827115143, H290827137251, H2908271406EE, H29082719DD0B, H290827206AA2, H290827217B2B, H2908272249B0, H290827235839, H290827253D0F, H290827260F94, H29082728E6EA, 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H29147067E834, H2914706810C3, H29147069014A, H291470708553, H2914707194DA, H29147072A641, H29147073B7C8, H29147074C377, H29147075D2FE, H29147076E065, H29147077F1EC, H29147078091B, H291470791892, H29147080069B, H291470811712, H291470822589, H291470833400, H2914708440BF, H291470855136, H2914708663AD, H291470877224, H291470888AD3, H291470899B5A, H291470901F43, H291470910ECA, H291470923C51, H291470945967, H2914709548EE, H291470967A75, H291470976BFC, H29147098930B, H291470998282, H291471009287, H29147101830E, H29147102B195, H29147103A01C, H29147104D4A3, H29147105C52A, H29147106F7B1, H29147107E638, H291471081ECF, H291471090F46, H291471108B5F, H291471119AD6, H29147112A84D, H29147113B9C4, H29147114CD7B, H29147115DCF2, H29147116EE69, H29147117FFE0, H291471180717, H29147119169E, H29147120A137, H29147121B0BE, H291471228225, H2914712393AC, H29147124E713, H29147125F69A, H29147126C401, H29147127D588, H291471282D7F, H291471293CF6, H29147130B8EF, H29147131A966, H291471329BFD, H291471338A74, H29147134FECB, H29147135EF42, H29147136DDD9, H29147137CC50, H29148842F812, H29148843E99B, H291488449D24, H291488458CAD, H29148846BE36, H29148847AFBF, H291488485748, H2914884946C1, H29148850C2D8, H29148851D351, H29148852E1CA, H29148853F043, H2914885484FC, H291488559575, H29148856A7EE, H29148857B667, H291488584E90, H29148864AE94, H29148865BF1D, H291488668D86, H291488679C0F, H29148874B74C, H29148875A6C5, H29148876945E, H2914887785D7, H291488787D20, H2914888251B2, H291488843484, H29148885250D, H291488861796, H2914889359E3, H291488942D5C, H291488953CD5, H291488960E4E, H291488971FC7, H29148898E730, H29148899F6B9, H29148900E6BC, H291489097B7D, H29148910FF64, H29148911EEED, H29148912DC76, H29148913CDFF, H29148914B940, H29148915A8C9, H291489169A52, H291489178BDB, H29148918732C, H2914891962A5, H29148920D50C, H29148921C485, H29148922F61E, H29148923E797, H291489249328, H2914892582A1, H29148926B03A, H29148927A1B3, H291489285944, H2914892948CD, H29148930CCD4, H29148931DD5D, H29148938409C, H291489395115, H2914894081DC, H291489419055, H29148947F563, H29148951898D, H29148952BB16, H29148953AA9F, H29148954DE20, H29148955CFA9, H29148956FD32, H29148957ECBB, H29148958144C, H2914895905C5, H29148960B26C, H29148961A3E5, H29148962917E, H2914896380F7, H29148965E5C1, H291489683E24, H29148971BA3D, H2914897288A6, H29148973992F, H29148974ED90, H29148975FC19, H29148976CE82, H29148977DF0B, H2914897827FC, H291489793675, H29148980287C, H2914898139F5, H291489820B6E, H291489831AE7, H291489846E58, H291489857FD1, H291489864D4A, H291489875CC3, H29148988A434, H29148989B5BD, H2914899031A4, H29148999AC65, H291490006619, H291490017790, H29149002450B, H291490035482, H29149004203D, H2914900531B4, H29149006032F, H2914900712A6, H29149008EA51, H29149009FBD8, H291490107FC1, H2914901439E5, H29149015286C, H291490170B7E, H29149018F389, H29149019E200, H2914902055A9, H291490214420, H2914902276BB, H291490236732, H291490326F63, H291490337EEA, H2914904333E2, H29149044475D, H2914904556D4, H29149046644F, H2914904775C6, H291490488D31, H291490499CB8, H2914905018A1, H291490510928, H291490523BB3, H291490532A3A, H291490545E85, H291490554F0C, H291490567D97, H291490576C1E, H2914905894E9, H291490598560, H2914906032C9, H2914906211DB, H291490630052, H2914906474ED, H291490656564, H2914906657FF, H291490674676, H29149068BE81, H291490702B11, H291490713A98, H291490720803, H29149073198A, H291490746D35, H291490757CBC, H291490764E27, H291490775FAE, H29149078A759, H29149079B6D0, H29149090B101, H29149091A088, H291490929213, H29149093839A, H29149094F725, H29149095E6AC, H29149096D437, H29149097C5BE, H29149107487A, H29149108B08D, H291493914FEC, H291494256165, H291494320C02, H29149449FFD9, H29149675AA65, H291500293A4F, H2915137209FB, H29151385FE8C, H29151400EBE4, H291514097625, H29151415A591, H29151423EACF, H29151433F317, H291514408C84, H29151447F83B, H29151454D378, H29151475F141, H291514846300, H291514864012, H29151487519B, H29151488A96C, H291514903CFC, H291514947AD8, H2915156680DE, H29151577888F, H291515906620, H29151599FBE1, H2915161622B2, H29151683A207, H291516908944, H29151703361B, H291517145B7C, H291517265206, H291517357945, H291517516BB1, H291517627342, H291517740FAC, H29151786AF76, H291518004E47, H291518062B71, H291518216C7E, H2915183175A6, H291518420A35, H291518512176, H29151863280C, H29151874456B, H29151885D72A, H29151895CEF2, H291519054336, H291519166875, H29151926421D, H29151939A332, H29151948FFB3, H29151960404B, H291519705993, H29151982F949, H291519885613, H29152004EB6C, H29152014F2B4, H29152023AC63, H29152033B5BB, H29152042E93A, H29152053E16B, H29152063CB03, H29153121C916, H2915315819DF, H29153171B7AE, H2915318463CB, H291531974888, H291536071395, H29153608EB62, H29153609FAEB, H291536107EF2, H291536116F7B, H291536125DE0, H291536134C69, H2915361438D6, H29153615295F, H291536161BC4, H29153619E333, H29153620549A, H291536214513, H291536227788, H2915362412BE, H291536250337, H2915362631AC, H29153628D8D2, H29153629C95B, H291536304D42, H291536315CCB, H291536337FD9, H291536340B66, H291536362874, H2915363739FD, H29153638C10A, H29153639D083, H29153640004A, H2915364111C3, H291536422358, H29153646657C, H2915364774F5, H291536488C02, H291536499D8B, H291536501992, H29153651081B, H291536523A80, H291536532B09, H291536545FB6, H291551093D74, H29155114FF49, H29155117CDD2, H291551209305, H29155198FBE5, H291552026CC3, H29155208C399, H2915521722B6, H291552234EFA, H291552317430, H29155300150D, H2915530988CC, H29155328AAF5, H291553374BDA, H2915535248A7, H29155378D44D, H29155390C215, H291553984E5D, H29155406FC3E, H29155417F46F, H291554293779, H291554469B5E, H291554586BF8, H291554785848, H29155572ADCE, H2915569877E0, H291557566DE2, H2915576022BC, H29155768AEF4, H29155769BF7D, H2915585515BE, H291558671CC4, H29155892C8A1, H2915590354EC, H29155943338C, H2915595018CF, H291559567DF9, H2915596211B5, H29155981B93E, H291561486E50, H291561759FDD, H2915619360FB, H29156246684A, H29156298314C, H2915632331EB, H291563504E78, H291563752A65, H291564139786, H29156427FBCA, H291564390B6C, H291564906BDD, H291565169AF7, H29156565E564, H29156577DFAE, H291565903101, H291566212B44, H29157205210A, H291572106F7F, H291572135DE4, H291572204517, H29157223778C, H291572262021, H2915722731A8, H291572350B62, H29157243235C, H291572489D8F, H291572544E3B, H291572577CA0, H291572620165, H291572756C02, H29157280B867, H29157288342F, H29157295F612, H291573002C7B, H2915730758C4, H2915731216B1, H291573165095, H291573210E42, H2915732459EF, H29167986E93B, H291680024F38, H291680466E7C, H2916807313B9, H29168094FD16, H291681131DB5, H29168119B2EF, H291687864BD9, H29168842EE9A, H29168847B937, H291688495049, H29168851C5D9, H29168852F742, H291688549274, H2916885583FD, H29168857A0EF, H291688594991, H29168861EFB1, H29168865A995, H2916886963F9, H29168871F669, H29168872C4F2, H29168874A1C4, H29168886011E, H291688916C79, H29168933E8C7, H29168936BF6A, H29168937AEE3, H29168939479D, H2916894186DD, H29168942B446, H291689481B1C, H29168952AD9E, H29168954C8A8, H29168957FA33, H2916896287F6, H29168963967F, H29168965F349, H2916896828AC, H29168974FB18, H29168977C983, H291689830C6F, H291689865BC2, H291689874A4B, H29168992043E, H291689946108, H2916904451D5, H29169047634E, H291690500E29, H29169054480D, H291690577A96, H2916905993E8, H291690730F02, H29169078B1D1, H291690829D43, H29169084F875, H29169087CAEE, H291690892390, H29171285B2D8, H29171288693D, H29171290FCAD, H29171294BA89, H29171296999B, H2917129870E5, H29171299616C, H29171308FD21, H2917131068B1, H291713135A2A, H291713160D87, H291713171C0E, H2917132042D9, H2917132261CB, H2917132627EF, H29171333699A, H2917134541A4, H291713489A41, H291713511E58, H291713533D4A, H291713566AE7, H291713588399, H291713613430, H291713631722, H291713982A39, H2917140960AD, H29171411F53D, H29171412C7A6, H29171422EDCE, H29171423FC47, H29171429531D, H29171431C68D, H29171443A897, H291714591E15, H29171469347D, H29171470B064, H29171471A1ED, H29171474F640, H291714812225, H291714830137, H29171505F01D, H29171510BE68, H291715129D7A, H29171534CBFC, H29171545977D, H29171550D908, H2917156787DF, H291715916121, H2917160048D4, H291716051F79, H2917162349FF, H29171628F72C, H2917165127E5, H2917165304F7, H29171656535A, H29171658BA24, H29171659ABAD, H291716601C04, H291716610D8D, H291716623F16, H291716645A20, H291717001208, H291717100BD0, H291717144DF4, H291717188798, H291717199611, H2917172021B8, H291717213031, H2917172202AA, H29171726448E, H291717330AFB, H291717374CDF, H29171738B428, H29171739A5A1, H2917174701D7, H291717637443, H291717736D9B, H29171793F78B, H291718072C70, H291718502677, H2917185571DA, H291718600C1F, H29171871044E, H291718818786, H2917780544F8, H2917784165BC, H291778461103, H29177849E9F4, H291778553A40, H291800974BED, H29180160E646, H291801843A72, H291801971131, H29182545D84C, H29182577D136, H291825846065, H2918259479BD, H2918260224F7, H291826101E3D, H291826176A82, H291826247271, H291826320E9F, H291826424397, H29182647143A, H291826525A4F, H291826650498, H2918267269FF, H29182679D72C, H291852164F4B, H291852323ADF, H291852642151, H29185288712D, H291853161597, H29185357637E, H291854086934, H29185410FCA4, H2918582341F4, H291860093E11, H29186015EDA5, H2918601927C9, H291913571AD6, H291913604401, H291913615588, H291913626713, H29191363769A, H291913640225, H291913662137, H2919136730BE, H29191368C849, H29191369D9C0, H29191378D191, H29191379C018, H29191380DE11, H29191381CF98, H29191382FD03, H2919139481ED, H29191397B376, H291913995A08, H29191405CB79, H29191406F9E2, H29191408109C, H291914090115, H29191410850C, H29191413B797, H29191414C328, H291914180944, H29191420AF64, H29191421BEED, H291914228C76, H291914239DFF, H29191424E940, H29191426CA52, H2919143295AE, H291914338427, H29191

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1288-2023

Related Recalls

Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.

Oct 7, 2025 Other Medical Devices Nationwide View Details →