Recall archive / FDA device enforcement

Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea synd... — FDA record Z-1655-2022

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 26, 2022. 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: Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Reason: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Classification: Class I
Recalling firm: Philips Respironics, Inc.
Quantity: 1,091 units ***updated Jan 2024*** additional 323 units
Agency-reported status: Ongoing
Source record identifier: Z-1655-2022

Open the official record

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: 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, 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V29118589120B, V29118596F324, V291186028D7C, V291186192A77, V29118626F8E8, V291186281196, V29118631958F, V29118632A714, V29118636E130, V29118637F0B9, V29118643FB95, V29118650D0D6, V2911865496F2, V29118663C825, V30283017485A, V302830232416, V302830289AC5, V30283046276B, V302830550C28, V30283078E47D, V30283089763C, V302892521181, V30289293A9A8, V30289392E2FD, V3028946953E3, V302897712917, V3028980568FC, V3029003202CE, V30297028E36D, V30297138A069, V302971726853, V30301210EE20, V303012481CD0, V30301348460C, V3030138063E4, V30301762B987, V30315243DBAB, V3031534290FE, V303154655BF4, V303154710408, V30315484D06D, V303155256648, V30315538A475, V30315657E736, V30315667CD5E, V303283360D91, V30328422DE68, V30328477F77D, V303288272C66, V30329007C5AF, V30329199A115, V303299634B45, V303300342F7B, V3033004573FA, V3033123597F1, V30331283166F, V30334344FFFB, V3033444473FE, V303344564934, V303347953D6B, V30344673A84D, V30344703BF99, V30344812FD0F, V30344828783D, V30344856DC4B, V303449794DD0, 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V304140222B20, V3041410715E1, V30414252D390, V304142658D47, V304886399CA2, V30489683CBEB, V3048979927B5, V30493957A09A, V3049410309E5, V3049411575...

Label field

Details supplied by the agency

Lot, code or applicability

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, 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, V290847551FDC, V290847562D47, V291183973474, V29118398CC83, V29118399DD0A, V291184010A5F, V2911840238C4, V291184054C7B, V291184067EE0, V291184076F69, V29118408979E, V29118410020E, V291184111387, V29118412211C, V291184133095, V29118414442A, V2911841555A3, V291184166738, V2911841776B1, V291184202866, V2911842139EF, V291184220B74, V291184246E42, V291184257FCB, V291184275CD9, V29118428A42E, V2911843031BE, V291184312037, V2911843212AC, V29118434779A, V291184356613, V291184365488, V29118438BDF6, V29118439AC7F, V291184416D3F, V291184434E2D, V291184443A92, V29118450656E, V2911845532C3, V29118458E926, V29118468C34E, V2911847056DE, V291184772261, V291184849332, V29118487A1A9, V29118490CCCE, V291184948AEA, V291185037391, V29118506243C, V2911850735B5, V29118509DCCB, V291185216333, V2911852251A8, V291185324870, V29118539F6A3, V29118546435C, V29118549BBAB, V291185632741, V2911856453FE, V291185676165, V291185700C02, V291185711D8B, V29118587FB75, V291185880382, V29118589120B, V29118596F324, V291186028D7C, V291186192A77, V29118626F8E8, V291186281196, V29118631958F, V29118632A714, V29118636E130, V29118637F0B9, V29118643FB95, V29118650D0D6, V2911865496F2, V29118663C825, V30283017485A, V302830232416, V302830289AC5, V30283046276B, V302830550C28, V30283078E47D, V30283089763C, V302892521181, V30289293A9A8, V30289392E2FD, V3028946953E3, V302897712917, V3028980568FC, V3029003202CE, V30297028E36D, V30297138A069, V302971726853, V30301210EE20, V303012481CD0, V30301348460C, V3030138063E4, V30301762B987, V30315243DBAB, V3031534290FE, V303154655BF4, V303154710408, V30315484D06D, V303155256648, V30315538A475, V30315657E736, V30315667CD5E, V303283360D91, V30328422DE68, V30328477F77D, V303288272C66, V30329007C5AF, V30329199A115, V303299634B45, V303300342F7B, V3033004573FA, V3033123597F1, V30331283166F, V30334344FFFB, V3033444473FE, V303344564934, V303347953D6B, V30344673A84D, V30344703BF99, V30344812FD0F, V30344828783D, V30344856DC4B, V303449794DD0, V303449915B88, V303450032F27, V30346276A5F7, V303462914B58, V30346299C710, V30346300D715, V303463085B5D, V303463832B4E, V3034639774B2, V303464115341, V303464732483, V30346484D3F4, V3034649911C9, V303465516EFD, V30346587BBB3, V303466079A17, V30346614B154, V303469484F47, V303469549CF3, V303469558D7A, V30346989F76E, V303470121E00, V30347044058E, V303471588CE6, V3034717747A1, V30347179AEDF, V303471892D17, V303473910D3F, V30347404018F, V303474136CE8, V303474141857, V303474216592, V30347492B3A1, V30347514428B, V303475312696, V30347866D3EE, V303478683A90, V303478692B19, V303490795A41, V30349082675A, V303491691945, V30349172BE4E, V303491810F1D, V303582046EEB, V3035825364EC, V30358271744E, V30358280E60F, V303583153C66, V30358327351C, V30358339C5BA, V303583577814, V3036028549B6, V303602867B2D, V303602876AA4, V3036028983DA, V3036029007C3, V30360291164A, V3036029224D1, V303602933558, V3036029441E7, V30360295506E, V30360308064F, V3036030917C6, V30360316F6E9, V303603190E1E, V30360324FF93, V30360325EE1A, V30360326DC81, V30360330A06F, V3036033392F4, V30360335F7C2, V303603393DAE, V30360343DFFC, V30360344AB43, V30360351E536, V303603569189, V30360360DED7, V30360361CF5E, V30360362FDC5, V30360363EC4C, V303867822E96, V30387082BE28, V3038711233EC, V30387211EE13, V303873458C53, V303873778529, V303874030200, V30387606E015, V30387641F3CA, V30387672EB39, V303877999526, V30387822859A, V30387846976E, V30388056FA8D, V30388096532D, V30388113909C, V303882137FF8, V3038826557C6, V30388455AB77, V30388498D932, V30388535A57B, V30388567F8D1, V303886012653, V3038879927DF, V303888245255, V3038885148F0, V303889226DBF, V303889613844, V30389030D7D0, V30389043A843, V30389188E5EC, V303891943658, V30389199EDBD, V303902796AEE, V30390298E177, V303903169C15, V30390431571F, V303904373229, V3039049298F4, V30390594A71E, V30390620EAF6, V30390650A7FE, V303907569814, V30390776ABA4, V30390801D8D4, V30390913B8C2, V303909392428, V30390960C751, V303910321A5E, V30391243F367, V30391251C9AD, V3039140342DE, V303914657338, V303915064FAF, V303915311178, V303915473946, 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, V3061214403D6, V306121625550, V3061216521EF, V30612179F25B, V306121897193, V306142080A24, V306142497CCD, V30614250F8D4, V306142862D9A, V30614288C4E4, V306142905174, V30614322CC12, V30614324A924, V2887096492BB, V288709658332, V28870966B1A9, V28870967A020, V2887096858D7, V28870970CD47, V288709759AEA, V28870978410F, V288709795086, V288709815F06, V288709826D9D, V28875018E796, V28875019F61F, V28875021503F, V288750240792, V28875025161B, V288750262480, V288750273509, V28875028CDFE, V28875029DC77, V2887503149E7, V288750350FC3, V288750363D58, V288750372CD1, V288750401566, V2887504104EF, V288750423674, V2887504327FD, V288750445342, V2887504542CB, V288750467050, V2887504761D9, V288751527570, V2887515364F9, V288751541046, V288751563354, V2887515722DD, V28875159CBA3, V288751607C0A, V288751616D83, V288751634E91, V288751652BA7, V28875166193C, V28875183D481, V290843818AE1, V29084383A9F3, V29084385CCC5, V29084386FE5E, V29084387EFD7, V290843881720, V2908438906A9, V2908439082B0, V29084392A1A2, V29084396E786, V29084397F60F, V290953420625, V29095345729A, V290953464001, V290953475188, V290953547ACB, V290953556B42, V290953601687, V29095361070E, V29095363241C, V2909536450A3, V29095365412A, V2909536673B1, V290953689ACF, V290953698B46, V290953700F5F, V30392180A2F5, V30396087FE7A, V30396092B00F, V3041325284B1, V304134715343, V30413674B156, V30413896184F, V304140222B20, V3041410715E1, V30414252D390, V304142658D47, V304886399CA2, V30489683CBEB, V3048979927B5, V30493957A09A, V3049410309E5, V3049411575...

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

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Sep 14, 2022
Recall initiation date: Aug 26, 2022
Center classification date: Sep 8, 2022

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.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records