Back to search
FDAFDA · Food and drugs·Recall number Z-2037-2025

BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS

Published July 9, 2025 · Recall initiated: May 9, 2025

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

This device does not indicate for use in patients with respiratory failure.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Philips Respironics, Inc.
Distributor
Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (HU), Indonesia (ID), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), Korea, Republic of (KR), Lebanon (LB), Morocco (MA), Monaco (MC), Montenegro (ME), Mexico (MX), Malaysia (MY), Netherlands (NL), Norway (NO), Nepal (NP), Peru (PE), Philippines (PH), Pakistan (PK), Poland (PL), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudia Arabia (SA), Singapore (SG), Slovakia (SK), Thailand (TH), Turkey (TR), Taiwan (TW), Viet Nam (VN), South Africa (ZA).
Lot
US: A40 Material No. 1111169 UDI-DI 00606959039476 Serial Numbers V182393118CC9 V21942863DD70 V219429359C22 V25585948745C V26439189762A V2640770372E7 OUS: A40: Material No. 1111169 UDI-DI 00606959039476 Serial Numbers V09765327781A V09765332366F V097653405875 V097653436AEE V097653472CCA V0976535041AD V097653551600 V09765356249B V09765358CDE5 V100863961519 V10086398FC67 V10086399EDEE V100864020820 V10086408A77A V1008641032EA V100864112363 V100864130071 V1008641474CE V100864201882 V100864223B90 V100864276C3D V10086436646C V100864388D12 V100864399C9B V100864426F40 V100864437EC9 V100864462964 V10086448C01A V10086450558A V100864514403 V100864527698 V100864536711 V100864550227 V1008645630BC V10086459C84B V100864616E6B V100864634D79 V1008646439C6 V10086465284F V100864670B5D V10086468F3AA V1008643333C1 V1008647177B3 V100864724528 V100864771285 V10086478EA72 V10086479FBFB V1008648869BA V100864013ABB V100864267DB4 V100864451BFF V10086458D9C2 V100864625CF0 V100864753197 V10086484A3D6 V10086476030C V10086509EC2F V100865489AC6 V10086482C6E0 V1008643556F7 V100865124B24 V100865262768 V10086528CE16 V100865454123 V100864002B32 V100864415DDB V10086469E223 V1008650437CA V1008652370C5 V1008640319A9 V10086485B25F V10271624DE95 V10271625CF1C V10271627EC0E V1027162814F9 V102716290570 V102716308169 V1027163190E0 V10271633B3F2 V10271664B9F5 V102716943A3D V102716952BB4 V10271696192F V10271698F051 V10271699E1D8 V10271700F1DD V10271704B7F9 V1027170694EB V10271711F98C V10271712CB17 V10271713DA9E V10271714AE21 V10271726A75B V10271727B6D2 V10307238112D V103072449649 V10307246B55B V10307252EAA7 V103072548F91 V10307256AC83 V10307257BD0A V103072595474 V10307260E3DD V10307261F254 V10307262C0CF V10307265B470 V103072679762 V103072697E1C V10307271EB8C V10307274BC21 V10086542359C V10307250C9B5 V10307251D83C V1030726686EB V10307410780C V103074134A97 V103074161D3A V103074304BBC V1030742143ED V10390418F201 V102716082749 V102716183E91 V103072485C25 V10307272D917 V10307273C89E V103074116985 V10307438C7F4 V104077648095 V10407766A387 V10407767B20E V10407774994D V1040777588C4 V10407776BA5F V104077814D28 V104077827FB3 V10407831E347 V1030799049B3 V10307991583A V103079926AA1 V103079951E1E V10308004F668 V1039042366BA V104077850B0C V10407787281E V10407789C160 V104077904579 V10407792666B V1040779377E2 V1040779731C6 V10407798C931 V10407799D8B8 V10407800D8A6 V10407802FBB4 V10407806BD90 V10407811D0F7 V10407813F3E5 V1040781596D3 V104078184D36 V10407820EB16 V10407823D98D V104077695B70 V10407832D1DC V100864075F8D V10086409B6F3 V103080083C04 V10308017DD2B V10407828675E V10298868FB59 V10298869EAD0 V102988706EC9 V102988724DDB V102988735C52 V102988753964 V102988760BFF V102988771A76 V10298880ED01 V10298881FC88 V10298882CE13 V10298929D76C V107026380CB7 V107026391D3E V10702641DC7E V102988868837 V10702632A3ED V10878228A7F5 V108782303265 V1087823123EC V1087823565C8 V1087823746DA V1029891243D7 V108946784CA0 V109044236C3C V109044241883 V109044263B91 V109044272A18 V10904430477F V1090443156F6 V10904432646D V10904434015B V1090443510D2 V109044362249 V109044400A77 V109044411BFE V1090444338EC V109044444C53 V109044455DDA V109044466F41 V109044532134 V10904428D2EF V1090443375E4 V109045617292 V109045635180 V10904564253F V10904566062D V10904568EF53 V10904569FEDA V109045707AC3 V1090457259D1 V109045743CE7 V10904579E702 V10904580F90B V10904581E882 V10904585AEA6 V109045869C3D V1090458964CA V10904590E0D3 V10904595B77E V109045986C9B V10904600D8AF V10904601C926 V10904603EA34 V10904613F3EC V109046148753 V1090461596DA V10904617B5C8 V10904620EB1F V109046286757 V10904630F2C7 V10904633C05C V109046387E8F V109046429CDD V110222430981 V110222474FA5 V11022248B752 V1102225022C2 V108788983027 V1087902082BE V110452660125 V1104527618FD V110452770974 V11045282DD11 V11045285A9AE V10878904778F V108789102873 V1087891139FA V109045716B4A V10904609456E V110222361324 V11022249A6DB V1102281036D8 V110452743BEF V11045268E85B V110452707DCB V11070492618B V110704973626 V11022681E052 V1107049627AF V11081792F8A8 V11081796BE8C V11081797AF05
Risk classification
Class I
Area (FDA)
device
Country
United States

Sell products like this?

Recalert watches your whole catalog for recalls like this one, automatically.

Start free — no card