CLASS I ONGOING Device recall · Reported 14 Sep 2022 · FDA Enforcement Report

Philips BiPAP A40 recalled by Philips Respironics

Philips Respironics is recalling Philips BiPAP A40, distributed in 42 states. The recall was initiated on 26 Aug 2022 and the FDA has classified it as Class I.

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Lot, batch or date codesUDI-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, 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V30413876825F, V30560437402F, V30560801AAD2, V30560956FA09, V305820156B22, V30582155569E, V30583354EE14, V2887467968AD, V2887468076A4, V28874681672D, V2887468255B6, V28874683443F, V288746843080, V288746852109, V288746861392, V28874687021B, V28874689EB65, V288746906F7C, V288746917EF5, V288746924C6E, V288746935DE7, V288746942958, V2887469538D1, V288746960A4A, V288746971BC3, V28874698E334, V28874699F2BD, V28874700E2B8, V28874701F331, V28874702C1AA, V28874703D023, V28874704A49C, V28874705B515, V28874706878E, V288747079607, V288747086EF0, V288747097F79, V28874710FB60, V28874711EAE9, V28874713C9FB, V28874714BD44, V28874715ACCD, V288747169E56, V288747178FDF, V288747187728, V2887471966A1, V28874720D108, V28874721C081, V28874722F21A, V28874723E393, V28874724972C, V2887472586A5, V28874726B43E, V28874727A5B7, V288747285D40, V28874730C8D0, V28874731D959, V28874732EBC2, V28874733FA4B, V288747348EF4, V288747359F7D, V28874746E0EE, V288747480990, V28874752BF12, V28874756F936, V2887475901C1, V28874760B668, 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;

Quantity recalled1,091 units ***updated Jan 2024*** additional 323 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1655-2022
FDA event ID: 90695
Recalling firm: Philips Respironics, Murrysville, PA
Classification: Class I
Status: Ongoing
Recall initiated: 26 Aug 2022
FDA classified: 8 Sep 2022
Reported: 14 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: CPAP & Ventilators

Timeline

26 Aug 2022	Recall initiated by company
8 Sep 2022	Classified by FDA	+13 days
14 Sep 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.

Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maine Michigan

Questions about this recall

Is Philips BiPAP A40 recalled?

Yes. Philips Respironics recalled Philips BiPAP A40 on 26 Aug 2022. The recall is Class I and its status is Ongoing. Recall number Z-1655-2022.

Why was it recalled?

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

Which lots are affected?

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, V288884069522, V288884087C5C, V288884096DD5, V28888410E9CC, V28888412CADE, V28888413DB57, V28888415BE61, V288884168CFA, V288884179D73, V288884186584, V28888420C3A4, V28888421D22D, V28888422E0B6, V28888423F13F, V288884248580, V288884259409, V28888426A692, V28888427B71B, V288884284FEC, V288884349C58, V28888436BF4A, V28888437AEC3, V288884385634, V2888843947BD, V288884409774, V28888442B466, V28888444D150, V288884490AB5, V28888452ADBE, V28888457FA13, V2888845802E4, V28888461B54D, V28888468288C, V28888470BD1C, V288884729E0E, V288884738F87, V28888474FB38, V28888476D82A, V28888477C9A3, V2888847920DD, V288884821DC6, V288884830C4F, V288884856979, V288884865BE2, V28888488B29C, V28888489A315, V28888490270C, V288884913685, V28888492041E, V288884931597, V288884946128, V2888849570A1, V28888499BACD, V28888501BB41, V2888850289DA, V28888505FD65, V28888506CFFE, V288885093709, V28888510B310, V28888513818B, V288885183F58, V288885209978, V2888852188F1, V28888522BA6A, V28888523ABE3, V28888524DF5C, 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V30560437402F, V30560801AAD2, V30560956FA09, V305820156B22, V30582155569E, V30583354EE14, V2887467968AD, V2887468076A4, V28874681672D, V2887468255B6, V28874683443F, V288746843080, V288746852109, V288746861392, V28874687021B, V28874689EB65, V288746906F7C, V288746917EF5, V288746924C6E, V288746935DE7, V288746942958, V2887469538D1, V288746960A4A, V288746971BC3, V28874698E334, V28874699F2BD, V28874700E2B8, V28874701F331, V28874702C1AA, V28874703D023, V28874704A49C, V28874705B515, V28874706878E, V288747079607, V288747086EF0, V288747097F79, V28874710FB60, V28874711EAE9, V28874713C9FB, V28874714BD44, V28874715ACCD, V288747169E56, V288747178FDF, V288747187728, V2887471966A1, V28874720D108, V28874721C081, V28874722F21A, V28874723E393, V28874724972C, V2887472586A5, V28874726B43E, V28874727A5B7, V288747285D40, V28874730C8D0, V28874731D959, V28874732EBC2, V28874733FA4B, V288747348EF4, V288747359F7D, V28874746E0EE, V288747480990, V28874752BF12, V28874756F936, V2887475901C1, V28874760B668, 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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;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips Respironics

All 76

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS I	Trilogy Evo recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS I	Trilogy EV300 recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS I	Trilogy Evo Universal recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS I	Trilogy Evo O2 recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS I	Trilogy Evo recalled by Philips Respironics	Philips Respironics	Device Malfunction	Nationwide

Other CPAP & Ventilators recalls

All 552

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo-n recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
5 Aug 2026Device	CLASS I	Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled	ResMed	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical AG	Device Malfunction	Nationwide