Recall archive / FDA device enforcement

BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weig... — FDA record Z-2035-2025

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 May 9, 2025. 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: BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Reason: This device does not indicate for use in patients with respiratory failure.
Classification: Class I
Recalling firm: Philips Respironics, Inc.
Quantity: 5,958 units
Agency-reported status: Ongoing
Source record identifier: Z-2035-2025

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	Part Number 1111178; UDI: 0060959049635; Serial No. N2068642229E4, N206864244CD2, N206864255D5B, N206864277E49, N2068642886BE, N206864299737, N2068643102A7, N20686432303C, N2068643321B5, N20686434550A, N206864354483, N206864367618, N206864376791, N206864389F66, N206864398EEF, N206864405E26, N206864414FAF, N206864427D34, N206864441802, N20686445098B, N206864463B10, N206864472A99, N20686448D26E, N20686449C3E7, N2068645047FE, N206864515677, N2068645264EC, N206864537565, N2068645401DA, N206864551053, N2068645622C8, N206864573341, N20686458CBB6, N206864606D96, N206864617C1F, N206864624E84, N206864635F0D, N206864653A3B, N2068646608A0, N2070799636A7, N20708029041F, N20708103C229, N20708105A71F, N2070811974AB, N20708120C302, N20708137AE65, N20708141865B, N20708147E36D, N20713207A038, N20713212EE4D, N207132184117, N20713222C425, N20713232DDFD, N2071323872A7, N20713245E44A, N207132582677, N20713270998F, N207132810BCE, N2071329445BB, N2071329666A9, N207132977720, 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Label field

Details supplied by the agency

Lot, code or applicability

Part Number 1111178; UDI: 0060959049635; Serial No. N2068642229E4, N206864244CD2, N206864255D5B, N206864277E49, N2068642886BE, N206864299737, N2068643102A7, N20686432303C, N2068643321B5, N20686434550A, N206864354483, N206864367618, N206864376791, N206864389F66, N206864398EEF, N206864405E26, N206864414FAF, N206864427D34, N206864441802, N20686445098B, N206864463B10, N206864472A99, N20686448D26E, N20686449C3E7, N2068645047FE, N206864515677, N2068645264EC, N206864537565, N2068645401DA, N206864551053, N2068645622C8, N206864573341, N20686458CBB6, N206864606D96, N206864617C1F, N206864624E84, N206864635F0D, N206864653A3B, N2068646608A0, N2070799636A7, N20708029041F, N20708103C229, N20708105A71F, N2070811974AB, N20708120C302, N20708137AE65, N20708141865B, N20708147E36D, N20713207A038, N20713212EE4D, N207132184117, N20713222C425, N20713232DDFD, N2071323872A7, N20713245E44A, N207132582677, N20713270998F, N207132810BCE, N2071329445BB, N2071329666A9, N207132977720, N207132988FD7, N207132999E5E, 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N21892948F2CE, N2189297054EE, N218929736675, N218929750343, N218929772051, N21893003ABD8, N21893006FC75, N2189...

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

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).

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: Jul 9, 2025
Recall initiation date: May 9, 2025
Center classification date: Jul 2, 2025

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

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