Philips BiPAP A30 (Rx Only) Recall: VOCs from nonconforming plastic
Philips recalls BiPAP A30 devices with nonconforming plastic that may off-gas VOCs. Affected units have specific model and serial numbers. Contact Philips for details.
Lower-risk recall
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Contact the company
What happened, in plain English
Philips is recalling certain BiPAP A30 devices (Rx Only) that use nonconforming plastic parts. This can cause off-gassing of volatile organic compounds (VOCs), which may pose health risks to users. Read more at govinfonow.com/recall/60121-philips-bipap-a30-rx-only-recall-vocs-from-nonconforming-plastic.
Source Summary by GovInfoNow · govinfonow.com/recall/60121-philips-bipap-a30-rx-only-recall-vocs-from-nonconforming-plastic · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1654-2022
Cite this page
“Philips BiPAP A30 (Rx Only) Recall: VOCs from nonconforming plastic.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60121-philips-bipap-a30-rx-only-recall-vocs-from-nonconforming-plastic. Based on FDA recall #Z-1654-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1654-2022%22&limit=1).
Why it’s dangerous
The motor assemblies in these devices contain plastic that doesn't meet quality standards. This can lead to off-gassing of volatile organic compounds (VOCs), which may cause health issues over time, especially for people with respiratory conditions.
Who’s affected
Patients using the Philips BiPAP A30 for obstructive sleep apnea or respiratory insufficiency are most at risk. The recall affects specific model and serial numbers.
How to tell if you have this one
Check for model numbers 1109581-1111178 and serial numbers listed in the record. The recall was updated in January 2024.
- Brand
Philips Respironics- Category
Medical device
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1654-2022 | Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.; UDI-DI:606959042667, 606959042681, 606959042698, 606959042728, 606959067585, 606959067530; Model No.: 1109581, 1109582, 1109585, 1109588, 1109589, 1109590, 1109594, 1109596, 1109598, 1109601, 1111124, 1111150, 1111155, 1111169, 1111177, 1111178, 1116153, 1116156, CN1111143, CN1111169, R1111124, R1111177; Serial No.: N287725308B25, N28870219ADAE, N288702267F31, N2887023003DF, N288702473A68, N28870248C29F, N2887025723B0, N28870279F97E, N28870300736B, N2887030162E2, N2887030341F0, N288703153D1E, N288703341F27, N28870339C4C2, N288703423719, N2887034989CA, N288703533F48, N288710382694, N28871040E7D4, N28871042C4C6, N28871043D54F, N28871045B079, N28871047936B, N288710486B9C, N28872243453A, N28872424B38C, N28872434AA54, N30471136FB91, N304711485FE7, N30471153F8EC, N30471195347A, N30471199FE16, N3047120278B9, N304754069AA8, N30475435825B, N304754394837, N30475443AA65, N30475445CF53, N3047544814B6, N306144680873, N30614484580F, N306146006553, N3061460174DA, N306146024641, N3061460357C8, N3061460532FE, N3061461619BD, N30614661200A, N3061467139D2, N3061469380D0, N3061471314CC, N3061473453C3, N306147376158, N30614793DA0C, N30614795BF3A, N306148142AB4, N306148336DBB, N30614918BA04, N306149333767, N30614983D3CF, N306150028C23, N306150218D08, N288885978931, N28888599604F, N28888601D47B, N28888602E6E0, N28888605925F, N28888606A0C4, N288886095833, N28888611CDA3, N28888613EEB1, N28888617A895, N290848821182, N2908488657A6, N29084889AF51, N290848964E7E, N290848975FF7, N29084900A68C, N29118378D6CD, N29118379C744, N29118381C8C4, N29118382FA5F, N29118383EBD6, N291183849F69, N291183858EE0, N291183885505, N29118390C095, N29118391D11C, N29118392E387, N29118393F20E, N2911839486B1, N291183959738, N29118380D94D, N29118387ADF2, N29118396A5A3, N2874293301D1, N287429470AFD, N28742976311C, N290952904FCD, N290952915E44, N290952926CDF, N290952937D56, N2909529409E9, N290952951860, N290952962AFB, N290952973B72, N29095298C385, N29095299D20C, N29095300C209, N29095301D380, N29095302E11B, N29095303F092, N2909530595A4, N29095306A73F, N29095307B6B6, N290953084E41, N290953095FC8, N29095310DBD1, N29095311CA58, N29095312F8C3, N29095313E94A, N290953149DF5, N290953158C7C, N29095316BEE7, N290953185799, N290953194610, N29095320F1B9, N29095321E030, N29095322D2AB, N29095323C322, N29095324B79D, N29095325A614, N29095326948F, N290953278506, N290953287DF1, N290953296C78, N29095330E861, N29095331F9E8, N29095332CB73, N29095333DAFA, N29095334AE45, N29095335BFCC, N290953368D57, N290953379CDE, N290953386429, N2909533975A0; ***updated Jan 2024***N30471136FB91, N304711485FE7, N30471153F8EC, N30471195347A, N30471199FE16, N3047120278B9, N304754069AA8, N30475435825B, N304754394837, N30475443AA65, N30475445CF53, N3047544814B6, N306144680873, N30614484580F, N306146006553, N3061460174DA, N306146024641, N3061460357C8, N3061460532FE, N3061461619BD, N3061467139D2, N3061469380D0, N3061471314CC, N3061473453C3, N30614795BF3A, N306148142AB4, N306149333767, N30614983D3CF, N306150028C23, N306150218D08; | 146 units ***updated January 2024*** 30 additional units |
| Z-1655-2022 | Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.; 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, 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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; | 1,091 units ***updated Jan 2024*** additional 323 units |
| Z-1656-2022 | Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.; UDI-DI: 606959039377, 606959067936; Model No.: 1111155, 1111178; Serial No. N2908453138CE, N290845949213, N2909527493F9, N286646884854, N28664691CC4D, N28664692FED6, N28664693EF5F, N286646949BE0, N286646958A69, N28664696B8F2, N28664697A97B, N28664698518C, N286646994005, N286647005000, N286647014189, N286647027312, N28664703629B, N286647041624, N2866470507AD, N2866470724BF, N28664708DC48, N288710497A15, N28871061C5ED, N28871062F776, N28871063E6FF, N28888622D550, N28888623C4D9, N28888624B066, N28888625A1EF, N288886269374, N2888862782FD, N288886287A0A, N28888630EF9A, N28888631FE13, N28888632CC88, N28888633DD01, N28888634A9BE, N28888635B837, N288886368AAC, N288886379B25, N2888863863D2, N28888639725B, N28888640A292, N28888641B31B, N288886428180, N288886439009, N28888644E4B6, N28888645F53F, N28888646C7A4, N29084339625F, N29084340B296, N29084341A31F, N290843429184, N29084343800D, N29084344F4B2, N29084345E53B, N29084346D7A0, N29084347C629, N290843483EDE, N290843492F57, N29084350AB4E, N29084351BAC7, N29084352885C, N2908435399D5, N29084354ED6A, N29084355FCE3, N29084356CE78, N29084357DFF1, N290843582706, N29084359368F, N290843608126, N2908436190AF, N29084362A234, N29084363B3BD, N29084364C702, N29084365D68B, N29084366E410, N29084367F599, N290843691CE7, N29084520309F, N290845230204, N290845256732, N290845274420, N29084528BCD7, N290845357EEA, N290845364C71, N29084539B486, N2908454175C6, N2908454356D4, N2908454533E2, N29084548E807, N290845525E85, N290845552A3A, N2908455618A1, N290845570928, N29084558F1DF, N29084559E056, N2908456057FF, N290845614676, N2908456274ED, N290845636564, N2908456411DB, N290845650052, N2908456632C9, N290845672340, N29084568DBB7, N29084569CA3E, N290845704E27, N290845715FAE, N290845726D35, N290845737CBC, N290845740803, N29084575198A, N290845762B11, N290845773A98, N29084578C26F, N29084579D3E6, N29084580CDEF, N29084581DC66, N29084582EEFD, N29084583FF74, N290845848BCB, N290845859A42, N29084586A8D9, N29084587B950, N2908458841A7, N29084589502E, N29084590D437, N29084591C5BE, N29084592F725, N29084593E6AC, N29084595839A, N29084596B101, N29084597A088, N2908459949F6, N29084600EC4B, N29084601FDC2, N29084602CF59, N29084603DED0, N29084604AA6F, N29084605BBE6, N29084606897D, N2908460798F4, N290846086003, N29084609718A, N29084610F593, N29084611E41A, N29084612D681, N29084613C708, N2908461690A5, N29084617812C, N2908461879DB, N290846196852, N29084620DFFB, N29084621CE72, N29084622FCE9, N29084623ED60, N2908462499DF, N29084626BACD, N29084627AB44, N2908462853B3, N29084629423A, N29084630C623, N29084631D7AA, N290952392F7C, N29095240FFB5, N29095241EE3C, N29095242DCA7, N29095243CD2E, N29095244B991, N29095245A818, N290952469A83, N290952478B0A, N2909524873FD, N290952496274, N29095250E66D, N29095251F7E4, N29095252C57F, N29095253D4F6, N29095254A049, N29095255B1C0, N29095256835B, N2909525792D2, N290952586A25, N290952597BAC, N29095260CC05, N29095261DD8C, N29095262EF17, N29095263FE9E, N290952648A21, N290952659BA8, N29095266A933, N29095267B8BA, N29095268404D, N2909526951C4, N29095270D5DD, N29095271C454, N29095272F6CF, N29095273E746, N290952758270, N29095276B0EB, N29095277A162, N290952785995, N29095279481C, N290952805615, N29095281479C, N290952827507, N29095283648E, N290952841031, N2909528501B8, N290952863323, N2909528722AA, N29095288DA5D, N304507466A73, N304507510714, N304507532406, N304507554130, N304508550BF7, N30450858D012, N304508625520, N30450869EBF3, N3045094548F3, N30450951170F, N3045095663B0, N3045101795FC, N304510248D0F, N30451032F1E1, N30451037A64C, N304510913E0A, N30451095782E, N30451098A3CB, N30451101B3CE, N30451159413E, N30451164B0B3, N304511678228, N30451170EF4F, N3045521752A8, N304552211DF6, N304552266949, N30455231042E, N304552770678, N30455280F10F, N30455283C394, N304552869439, N30455308E95B, N30455309F8D2, N304553170874, N30455318F083, N304553554C06, N30455359866A, N304553630358, N30455365666E, N30455385FC7E, N30455386CEE5, N30455390B20B, N30505287A7CF, N30505346453A, N305053547FF0, N305053632127, N305053711BED, N305053777EDB, N30505383BB37, N30505387FD13, N305053909074, N30505395C7D9, N30505978F556, N30506053C1E6, N30506054B559, N30506055A4D0, N3050605787C2, N305060587F35, N305060596EBC, N30506060D915, N30506063EB8E, N305538189694, N30553830296C, N305538357EC1, N3055384533C9, N30553891C595, N30553893E687, N3055389583B1, N30553896B12A, N305539430C23, N305539474A07, N30553949A379, N3055395570CD, N305539881B50, N305539919F49, N30553996EBF6, N305539991301, N30554041E40E, N30554043C71C, N3055404879CF, N30554051FDD6, N306372146A8B | 295 units |
| Z-1657-2022 | Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.; UDI-DI: 606959028791; Model No.: 1109581; Serial No. L28664716B714, L28664717A69D, L286647185E6A, L286647194FE3, L28664720F84A, L28664721E9C3, L28664722DB58, L28664723CAD1, L28664724BE6E, L28870984130F, L288709850286, L28870986301D, L288709872194, L28870988D963, L28870989C8EA, L288709904CF3, L288709915D7A, L288709926FE1, L288709937E68, L288709940AD7, L288709951B5E, L2887099629C5, L28870997384C, L28870998C0BB, L28870999D132, L288710001B4E, L288710010AC7, L28871002385C, L2887100329D5, L288710045D6A, L288710054CE3, L288710067E78, L288710076FF1, L288710089706, L28871009868F, L288710100296, L288710122184, L28871013300D, L2887101444B2, L28871015553B, L2887101667A0, L288710177629, L288710188EDE, L288710199F57, L2887102028FE, L288710213977, L288710220BEC, L288710231A65, L288710246EDA, L288710257F53, L288710264DC8, L288710275C41, L28871028A4B6, L28871029B53F, L288710303126, L2887103120AF, L288710321234, L2887103303BD, L290846327ECB, L290846336F42, L290846341BFD, L290846350A74, L2908463638EF, L29084638D191, L29084639C018, L2908464010D1, L290846410158, L2908464233C3, L29084643224A, L2908464456F5, L2908464675E7, L29084647646E, L290846489C99, L290846498D10, L290846500909, L290846511880, L290846522A1B, L290846533B92, L290846544F2D, L290846555EA4, L290846566C3F, L303986996DE3, L30398708F1AE, L3039884141C8, L304097046ACC | 85 units |
| Z-1658-2022 | Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.; UDI-DI: 606959029415, 606959028791; Model No.: 1109582, 1109585; Serial No. L28664715858F, L286647269D7C, L286647278CF5, L28870204F469, L28870206D77B, L28870207C6F2, L288702092F8C, L28870210AB95, L28870211BA1C, L288702128887, L28870214EDB1, L28870215FC38, L28870216CEA3, L28870217DF2A, L290843744520, L2908437554A9, L290843766632, L2908437777BB, L290843788F4C, L290843799EC5, L30396148EE55, L3039822431CF, L3039826456AF, L303982733BC8, L3039831335C4, L303983231FAC, L30398354261B, L30398416EE6C, L30398476BABC, L303984836ED9, L30398524BDCA, L30398531F3BF, L3039856810C6, L28664713E0B9; ***January 2024 Update *** L28664709563B, L28664710D222, L28664712F130; | 34 units ***updated January 2024 *** additional 3 units |
| Z-1659-2022 | Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.; UDI-DI: 606959067837, 606959068001; Model No.: 1111124, R1111124; Serial No. L29084645477C, L303986771E8D, L303987043BC2, L3039871356A5, L30398768A57E, L303987892EE7, L30398795FD53, L30398849CD80 | 8 units |
What to do — step by step
Check Device Details
Verify your model number and serial number against the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed in 42 states, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the device immediately?
No, the recall does not require immediate discontinuation. Affected units should be checked against the list.
Similar recalls
Other Philips Respironics recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1654-2022 (August 26, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1654-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.