Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Class I - Dangerous

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    UDI-DI: 606959042742, 606959042766, 606959042797, 606959067677, 606959067714, 606959042834, 606959067752, 606959067721, 606959068025; Model No.: 1109596, 1109598, 1109601, 1111169, 1111177, 1116153, 1116156, CN1111169, R1111177; Serial No.: V287427181CF7, V28772370BAC2, V28772449816E, V2877247036C7, V287782070507, V288703803DF5, V288703847BD1, V288703856A58, V2887038658C3, V28870387494A, V28870388B1BD, V28870389A034, V28870390242D, V2887039135A4, V28870392073F, V288703946209, V288703957380, V28870396411B, V288703975092, V28870398A865, V28870399B9EC, V288704007F30, V288704016EB9, V288704025C22, V288704043914, V28870405289D, V288704061A06, V288704070B8F, V28870408F378, V28870409E2F1, V2887041066E8, V288704117761, V2887041245FA, V288704135473, V288704171257, V28870418EAA0, V28870419FB29, V288704215D09, V288704226F92, V2887246677A0, V288724698F57, V28872472285C, V288724777FF1, V28872479968F, V288724808886, V28872485DF2B, V28872492B24C, V28872495C6F3, V288724981D16, V288725001C9A, 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V28874761A7E1, V288747683A20, V28874770AFB0, V288747728CA2, V288747739D2B, V28874774E994, V28874775F81D, V28874776CA86, V28874777DB0F, V2887477823F8, V288747793271, V288747802C78, V288747813DF1, V288747820F6A, V288747831EE3, V288747857BD5, V2887478758C7, V28874788A030, V28874789B1B9, V2887479035A0, V288747912429, V288747947384, V28874795620D, V28888553E6EB, V28888562DD0A, V28888573D55B, V2888857682F6, V2888858710B7, V290847573CCE, V29084758C439, V29084759D5B0, V290847617390, V29084762410B, V290847635082, V29084764243D, V2908476535B4, V29084766072F, V29084768EE51, V290847707BC1, V290847716A48, V2908477258D3, V28874771BE39, V28874793073B, V2888855583DD, V28888560FE18, V28888561EF91, V28888563CC83, V290846576612, V290846589EE5, V290846598F6C, V2908466038C5, V29084661294C, V29084697CFB2, V290846983745, V2908469926CC, V2908470036C9, V290847012740, V2908470215DB, V290847030452, V2908470470ED, V290847056164, V2908470653FF, V30423267E4B8, V30423337C0DC, V30423340F96B, V30423341E8E2, V30423345AEC6, V304233478DD4, V30423351F13A, V30423361DB52, V304233648CFF, V304233684693, V30423370D303, V304234199617, V304234264488, V304234506CB6, V304234524FA4, V30428010A8A2, V30428100EBA6, V30428112D16C, V30428128545E, V30428174E08A, V30428188A92E, V3042820227D0, V304322297D59, V3043224386D3, V30432250AD90, V3043228891A0, V304322988878, V30432303BB6F, V30432340EE94, V304323468BA2, V30432350F74C, V30432353C5D7, V304324331D02, V30432438A3D1, V30432443500A, V304324859C9C, V30432497A656, V304325005F2D, V304325235E06, V304325307545, V3043253701FA, V30432593BAAE, V30432602935B, V30432607C4F6, V304326494AE8, V30432653FC6A, V30432657BA4E, V30432698EB19, V30432700EA95, V304327068FA3, V30432723EBBE, V3043272944E4, V30432730C0FD, V30432752B73F, V30432775F030, V3043279658BB, V30432842E420, V30432846A204, V30432851CF63, V3043287799E5, V3043289166C3, V3043289703F5, V304329197E97, V304329248F1A, V30432935874B, V30432944DBCA, V30432955D39B, V3043295919F7, V304329628D4C, V304330401D4B, V304330454AE6, V304330489103, V30433081A562, V304330838670, V3043308838A3, V304331267671, V304331333804, V3043313886D7, V304331404797, V3043316346BC, V304331742BDB, V304331753A52, V304331978350, V30437205EAD2, V304372280287, V30437233A58C, V30437236F221, V304372381B5F, V304372390AD6, V30437240DA1F, V30440538F0A7, V30440579864E, V304405919016, V304406029AF1, V3044074195D6, V304407509D87, V30440757E938, V30440771BFBE, V304409168FCA, V30440921D11D, V30440937ADF3, V30440944D260, V30441119AD44, V30441129872C, V304411462B0B, V30441159CA24, V30443352F839, V304433687D0B, V304433842D77, V304434031B0D, V30443642D85C, V30443740A192, V30443744E7B6, V30443747D52D, V304440111587, V3044402579CB, V3044414754D5, V2909534134BE, V290953503CEF, V29095358B0A7, V305001089095, ***update January 2024 *** V304755366A42, V30475549DFBD, V304755541D80, V30475558D7EC, V30475666FB9E, V3047566812E0, V304756780B38, V30475684429C, V3047568888F0, V30475772FEBE, V3047577851E4, V304757836CFF, V30475835A7A6, V304758429E11, V30475848314B, V30475851B552, V30475933984C, V30475938269F, V30475943D544, V30475952DD15, V304760345520, V304760367632, V3047603767BB, V304760398EC5, V30476143364B, V30476147706F, V304761499911, V304761523E1A, V30479219BA34, V304792222E8F, V3047922668AB, V30479229905C, V30479293DBAE, V304792968C03, V304793720AEB, V30479384EC15, V30479387DE8E, V304793882679, V30612179F25B, V306121897193, V306142080A24, V30614250F8D4, V306142862D9A, V30614322CC12, V30614324A924, V28870971DCCE, V28870972EE55, V28870977B9F8, V2887502041B6, V288750327B7C, V288750336AF5, V288750341E4A, V288751643A2E, V28875169E1CB, V288751735749, V290843809B68, V29084384DD4C, V29084393B02B, V29084394C494, V29084395D51D, V290953446313, V29095348A97F, V290953530E74, V290953722C4D, V290953733DC4, V303918094827, V30391949759B, V303920012760, V30392018A379, V303921983765, V3039604311FE, V304134357207, V30413454375E, V30413553193D, V304135908206, V30413617D71D, V30413701F12F, V304138585891, V304140436E79, V30414056200C, V30414257843D, V30414725D39A, V30419201143C, V304885482F47, V30488578052F, V304885945553, V304886404C6B, V304886440A4F, V304886625CC9, V3048870071D7, V304887124B1D, V30488718E447, V304887341D9B, V304887476208, V304896734823, V304896743C9C, V304896761F8E, V304896770E07, V30489682DA62, V30489685AEDD, V304896869C46, V30489692C3BA, V30489693D233, V30489694A68C, V30489695B705, V3048971257A6, V30489713462F, V304897152319, V30489717000B, V304897236C47, V3048972418F8, V304897263BEA, V304897272A63, V30489733759F, V304897340120, V3048973510A9, V304897362232, V30489742291E, V304897433897, V304897444C28, V304897466F3A, V3048975013D4, V3048975230C6, V30489753214F, V304897554479, V3048976039BC, V304897647F98, V304897656E11, V304897665C8A, V304897746640, V304897764552, V3048977754DB, V30489778AC2C, V30489795EDD9, V3049382485D5, V30493892044B, V30493962DD5F, V304940603572, V304940647356, V3049406562DF, V30494113103D, V304941277C71, V304941617E27, V3049417521DB, V30495245F86C, V3049543740AF, V30495438B858, V30495448F550, V30495459FD01, V304954705370, V3049554200D6, V30495559A7DD, V304955711825, V30495615E5B5, V30495616D72E, V30495617C6A7, V30495643FE3B, V304956817489, V30495698F090, V30495714AEE0, V3049942836B4, V30499482649E, V30499498D21C, V30499512E95A, V304997532A0B, V304997674647, V304997839A73, V305000172B66, V305001023FCF, V30500113379E, V305002738C2A, V3050031293AF, V30500323A84E, V3050057211A6, V3050058383E7, V30500605C775, V30500850FE7B, V30500863E688, V3050089411FF, V305010633CF1, V305010666B5C, V3050108909BB, V30501370F8D6, V305013861E28, V305014012852, V30501418AC4B, V30558986B265, V30558991DF02, V30560798AACC, V305608458B96, V305609079538, V30560970AC8F, V30561911F56D, V305620037674, V3056207885AF, V30562127593C, V305621443F77, V30562236BE09, V3057238539A2, V30572393454C, V30572459CFB3, V305724886E42, V305725043032, V30572519F20F, V30572529D867, V305725467440, V30572584FEF2, V30572607EDCD, V305726579375, V30572677A0C5, V30572710DA76, V30572721E197, V3057278779D1, V3057280198E0, V305728283691, V30572940B4D5, V30572941A55C, V3057294297C7, V30572943864E, V30572944F2F1, V30572945E378, V30572946D1E3, V30572947C06A, V30572957D9B2, V305730005310, V305730260596, V30573049A9B1, V305730818C59, V305730919581, V30573092A71A, V30581373906D, V30581382022C, V305813947EC2, V3058140425DF, V305814107A23, V3058142362D0, V305814340FB7, V305814362CA5, V305814545B67, V3058146126A2, V3058147468D7, V305815175440, V305815244CB3, V3058153544E2, V305815427D55, V305815515616, V3058155401BB, V305815635F6C, V305815770090, V305815896A26, V30581595B992, V30581607A2FC, V30581627914C, V305816528BE9, V305816709B4B, V30581681090A, V3058173285E5, V30581745BC52, V30581761C9C6, V30581822D6FA, V30581823C773, V30581824B3CC, V30581825A245, V3058182879A0, V30581837988F, V30581844E71C, V30581863A013, V305818681EC0, V30581874CD74, V305818855F35, V305818945764, V30581952C12E, V30581954A418, V30581963FACF, V30581967BCEB, V305819758621, V305819863772, V305819915A15, V305819962EAA, V3058202450C3, V305820311EB6, V3058203992FE, V305820505BEF, V30582063431C, V3058207179D6, V305821251B96, V30582131446A, V3058213630D5, V305821445ECF, V30582171230A, V30582186D47D, V3058325697DA, V3058328404B0, V305832851539, V3058328627A2, V30583287362B, V30583288CEDC, V305832905B4C, V305832941D68, V30583302F59A, V3058331598FD, V305833286970, V30583335AB4D, V30583345E645, V30583364C47C, V305833922282, V305834041CA9, V3058341514F8, V305834260C0B, V3058343615D3, V305834474952, V305834600E5D, V305834688215, V3058347672B3, V30583532092B, V305835442115, V3058355438CD, V305836178252, V305836196B2C, V30583622FF97, V305836258B28, V305836491594, V305837139EAA;
  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:
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Product Codes/Lot Numbers:

UDI-DI: 606959042742, 606959042766, 606959042797, 606959067677, 606959067714, 606959042834, 606959067752, 606959067721, 606959068025; Model No.: 1109596, 1109598, 1109601, 1111169, 1111177, 1116153, 1116156, CN1111169, R1111177; Serial No.: V287427181CF7, V28772370BAC2, V28772449816E, V2877247036C7, V287782070507, V288703803DF5, V288703847BD1, V288703856A58, V2887038658C3, V28870387494A, V28870388B1BD, V28870389A034, V28870390242D, V2887039135A4, V28870392073F, V288703946209, V288703957380, V28870396411B, V288703975092, V28870398A865, V28870399B9EC, V288704007F30, V288704016EB9, V288704025C22, V288704043914, V28870405289D, V288704061A06, V288704070B8F, V28870408F378, V28870409E2F1, V2887041066E8, V288704117761, V2887041245FA, V288704135473, V288704171257, V28870418EAA0, V28870419FB29, V288704215D09, V288704226F92, V2887246677A0, V288724698F57, V28872472285C, V288724777FF1, V28872479968F, V288724808886, V28872485DF2B, V28872492B24C, V28872495C6F3, V288724981D16, V288725001C9A, V288725010D13, V288725023F88, V288725032E01, V288725045ABE, V288725054B37, V288725100542, V2887251114CB, V288725122650, V2887251771FD, V28872518890A, V288725199883, V288725257887, V288725275B95, V28872528A362, V28872529B2EB, V2887253036F2, V28872531277B, V2887253215E0, V288725330469, V2887253470D6, V28872535615F, V2887253653C4, V28872537424D, V28872538BABA, V28872539AB33, V288725407BFA, V288725416A73, V2887254258E8, V288725434961, V288725452C57, V288725461ECC, V288725470F45, V28872548F7B2, V28872549E63B, V288725506222, V2887255173AB, V288725524130, V2887255350B9, V288725542406, V28872555358F, V288725560714, V28872557169D, V28872558EE6A, V28872559FFE3, V28872560484A, V2887256159C3, V288725626B58, V288725637AD1, V288725640E6E, V288725651FE7, V288725662D7C, V288725673CF5, V28872568C402, V28872569D58B, V288725705192, V28872571401B, V288725727280, V288725736309, V2887257417B6, V28872575063F, V2887257634A4, V28872577252D, V28872578DDDA, V28872579CC53, V28872580D25A, V28872581C3D3, V28872582F148, V28872583E0C1, V28872584947E, V2887258585F7, V28872586B76C, V28872590CB82, V28872591DA0B, V28872592E890, V28872593F919, V288725948DA6, V288725959C2F, V28872597BF3D, V2887259847CA, V288725995643, V28872601E277, V28872602D0EC, V28872605A453, V2887260696C8, V288726078741, V288726096E3F, V28872611FBAF, V28872612C934, V28872613D8BD, V28872614AC02, V28872615BD8B, V288726168F10, V288726179E99, V28872618666E, V28872620C04E, V28872621D1C7, V28872622E35C, V28872623F2D5, V28872624866A, V2887262597E3, V28872626A578, V28872627B4F1, V288726284C06, V288726295D8F, V28872630D996, V28872631C81F, V28872632FA84, V28872633EB0D, V288726358E3B, V28872636BCA0, V28872637AD29, V288726394457, V28872644D2BA, V2887278067E2, V288728509D5D, V28872870AEED, V28872877DA52, V288728802D25, V28872889B0E4, V2887289034FD, V288728930666, V28872900B939, V288729208A89, V28874377B86E, V288743784099, V288743795110, V28874797411F, V28874798B9E8, V28874799A861, V28874800A87F, V28874801B9F6, V288748028B6D, V288748039AE4, V28874804EE5B, V28874805FFD2, V28874806CD49, V28874807DCC0, V288748082437, V2887480935BE, V28874810B1A7, V28874811A02E, V2887481292B5, V28874813833C, V28874814F783, V28874815E60A, V28874816D491, V28874817C518, V288748183DEF, V288748192C66, V288748209BCF, V288748218A46, V28874823A954, V28874824DDEB, V28874825CC62, V28874826FEF9, V28874827EF70, V288748281787, V28874829060E, V288748308217, V28874831939E, V28874832A105, V28874833B08C, V28874834C433, V28874835D5BA, V28874836E721, V28874837F6A8, V288748380E5F, V288748391FD6, V28874840CF1F, V28874841DE96, V28874842EC0D, V28874843FD84, V28874844893B, V2887484598B2, V28874846AA29, V28874847BBA0, V288748484357, V2887484952DE, V28874851C74E, V28874853E45C, V2887485490E3, V28874855816A, V28874856B3F1, V288748594B06, V28874860FCAF, V28874861ED26, V28874864BA8B, V28874865AB02, V288748669999, V28888376542F, V2888837745A6, V28888378BD51, V28888385E57C, V28888387C66E, V288883892F10, V28888395FCA4, V28888396CE3F, V28888401E19D, 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V28888525CED5, V28888526FC4E, V28888527EDC7, V288885281530, V2888852904B9, V2888853080A0, V28888532A3B2, V28888533B23B, V28888535D70D, V28888536E596, V28888537F41F, V288885380CE8, V28888541DC21, V28888542EEBA, V28888543FF33, V288885448B8C, V288885459A05, V28888546A89E, V290847074276, V29084708BA81, V29084709AB08, V290847102F11, V290847113E98, V290847120C03, V290847131D8A, V290847146935, V2908471578BC, V290847164A27, V290847175BAE, V29084718A359, V29084719B2D0, V290847200579, V2908472114F0, V29084722266B, V2908472337E2, V29084724435D, V2908472552D4, V29084726604F, V2908472771C6, V290847288931, V2908472998B8, V290847301CA1, V290847310D28, V290847323FB3, V290847332E3A, V290847345A85, V290847354B0C, V290847367997, V29084737681E, V2908473890E9, V290847398160, V2908474051A9, V290847414020, V2908474272BB, V290847436332, V29084744178D, V290847450604, V29084746349F, V290847472516, V29084748DDE1, V29084749CC68, V290847504871, V2908475159F8, V290847526B63, V290847537AEA, V290847540E55, 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V304330454AE6, V304330489103, V30433081A562, V304330838670, V3043308838A3, V304331267671, V304331333804, V3043313886D7, V304331404797, V3043316346BC, V304331742BDB, V304331753A52, V304331978350, V30437205EAD2, V304372280287, V30437233A58C, V30437236F221, V304372381B5F, V304372390AD6, V30437240DA1F, V30440538F0A7, V30440579864E, V304405919016, V304406029AF1, V3044074195D6, V304407509D87, V30440757E938, V30440771BFBE, V304409168FCA, V30440921D11D, V30440937ADF3, V30440944D260, V30441119AD44, V30441129872C, V304411462B0B, V30441159CA24, V30443352F839, V304433687D0B, V304433842D77, V304434031B0D, V30443642D85C, V30443740A192, V30443744E7B6, V30443747D52D, V304440111587, V3044402579CB, V3044414754D5, V2909534134BE, V290953503CEF, V29095358B0A7, V305001089095, ***update January 2024 *** V304755366A42, V30475549DFBD, V304755541D80, V30475558D7EC, V30475666FB9E, V3047566812E0, V304756780B38, V30475684429C, V3047568888F0, V30475772FEBE, V3047577851E4, V304757836CFF, V30475835A7A6, 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V30414056200C, V30414257843D, V30414725D39A, V30419201143C, V304885482F47, V30488578052F, V304885945553, V304886404C6B, V304886440A4F, V304886625CC9, V3048870071D7, V304887124B1D, V30488718E447, V304887341D9B, V304887476208, V304896734823, V304896743C9C, V304896761F8E, V304896770E07, V30489682DA62, V30489685AEDD, V304896869C46, V30489692C3BA, V30489693D233, V30489694A68C, V30489695B705, V3048971257A6, V30489713462F, V304897152319, V30489717000B, V304897236C47, V3048972418F8, V304897263BEA, V304897272A63, V30489733759F, V304897340120, V3048973510A9, V304897362232, V30489742291E, V304897433897, V304897444C28, V304897466F3A, V3048975013D4, V3048975230C6, V30489753214F, V304897554479, V3048976039BC, V304897647F98, V304897656E11, V304897665C8A, V304897746640, V304897764552, V3048977754DB, V30489778AC2C, V30489795EDD9, V3049382485D5, V30493892044B, V30493962DD5F, V304940603572, V304940647356, V3049406562DF, V30494113103D, V304941277C71, V304941617E27, V3049417521DB, V30495245F86C, V3049543740AF, V30495438B858, V30495448F550, V30495459FD01, V304954705370, V3049554200D6, V30495559A7DD, V304955711825, V30495615E5B5, V30495616D72E, V30495617C6A7, V30495643FE3B, V304956817489, V30495698F090, V30495714AEE0, V3049942836B4, V30499482649E, V30499498D21C, V30499512E95A, V304997532A0B, V304997674647, V304997839A73, V305000172B66, V305001023FCF, V30500113379E, V305002738C2A, V3050031293AF, V30500323A84E, V3050057211A6, V3050058383E7, V30500605C775, V30500850FE7B, V30500863E688, V3050089411FF, V305010633CF1, V305010666B5C, V3050108909BB, V30501370F8D6, V305013861E28, V305014012852, V30501418AC4B, V30558986B265, V30558991DF02, V30560798AACC, V305608458B96, V305609079538, V30560970AC8F, V30561911F56D, V305620037674, V3056207885AF, V30562127593C, V305621443F77, V30562236BE09, V3057238539A2, V30572393454C, V30572459CFB3, V305724886E42, V305725043032, V30572519F20F, V30572529D867, V305725467440, V30572584FEF2, V30572607EDCD, V305726579375, V30572677A0C5, V30572710DA76, V30572721E197, V3057278779D1, V3057280198E0, V305728283691, V30572940B4D5, V30572941A55C, V3057294297C7, V30572943864E, V30572944F2F1, V30572945E378, V30572946D1E3, V30572947C06A, V30572957D9B2, V305730005310, V305730260596, V30573049A9B1, V305730818C59, V305730919581, V30573092A71A, V30581373906D, V30581382022C, V305813947EC2, V3058140425DF, V305814107A23, V3058142362D0, V305814340FB7, V305814362CA5, V305814545B67, V3058146126A2, V3058147468D7, V305815175440, V305815244CB3, V3058153544E2, V305815427D55, V305815515616, V3058155401BB, V305815635F6C, V305815770090, V305815896A26, V30581595B992, V30581607A2FC, V30581627914C, V305816528BE9, V305816709B4B, V30581681090A, V3058173285E5, V30581745BC52, V30581761C9C6, V30581822D6FA, V30581823C773, V30581824B3CC, V30581825A245, V3058182879A0, V30581837988F, V30581844E71C, V30581863A013, V305818681EC0, V30581874CD74, V305818855F35, V305818945764, V30581952C12E, V30581954A418, V30581963FACF, V30581967BCEB, V305819758621, V305819863772, V305819915A15, V305819962EAA, V3058202450C3, V305820311EB6, V3058203992FE, V305820505BEF, V30582063431C, V3058207179D6, V305821251B96, V30582131446A, V3058213630D5, V305821445ECF, V30582171230A, V30582186D47D, V3058325697DA, V3058328404B0, V305832851539, V3058328627A2, V30583287362B, V30583288CEDC, V305832905B4C, V305832941D68, V30583302F59A, V3058331598FD, V305833286970, V30583335AB4D, V30583345E645, V30583364C47C, V305833922282, V305834041CA9, V3058341514F8, V305834260C0B, V3058343615D3, V305834474952, V305834600E5D, V305834688215, V3058347672B3, V30583532092B, V305835442115, V3058355438CD, V305836178252, V305836196B2C, V30583622FF97, V305836258B28, V305836491594, V305837139EAA;

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1655-2022

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 →