Philips Respironics, Inc. medical device recall: BiPAP V30 Auto Ventilator. Intended to provide non-invasive…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96948
- Recall initiated
- May 9, 2025
- Classified by FDA
- Jul 2, 2025
- Posted in Enforcement Report
- Jul 9, 2025
- Recalling firm
- Philips Respironics, Inc.
- Firm location
- Murrysville, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
This device does not indicate for use in patients with respiratory failure.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on May 9, 2025. FDA classified it 54 days later, on Jul 2, 2025. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: 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… Philips Respironics, Inc. has 27 recalls in our records.
Recalled products (3)
Z-2035-2025 Class I Ongoing
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Codes / lots: 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,…
Quantity: 5,958 units
Z-2036-2025 Class I Ongoing
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
Codes / lots: BiPAP A30 Part No. 1111143, 1111144, CN1111143, 1111145, 1111147, 1111149, 1111148, 1111150, 1116155, BR1111143, 1111144M, 1111144L, 1111144V, R1076491, 1111154, R1111143, 1101109, 1109594, 1076540, 1076581, 1076583, 1076582, 1111145, 1076581, ; UDI: 00606959021532, 00606959039308, 00606959039315, 00606959039339, 00606959039346, 00606959039353, 00606959039360, 00606959039384, 00606959039391, 00606959042728, 00606959048744, 00606959048751, 00606959048768, 00606959067530, 00606959067660, 00606959412675, 00606959412699; Serial No. N09765363D900, N097653668EAD, N097653679F24, N10271255612B, N1027125653B0, N102712632E75, N102712654B43, N1027126679D8, N1027126890A6, N10271275529B, N10271282A5EC, N10271287F241, N102712880AB6, N102712891B3F, N10271294D902, N10271297EB99, N10271298136E, N1027129902E7, N102713122828, N1027131996FB, N1027132576FF, N102713374C35, N10271476B6D9, N10271511CC6A,…
Quantity: 3 units in US 22,416 units and 49 units OUS
Z-2037-2025 Class I Ongoing
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
Codes / lots: 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…
Quantity: 6 units in US 67534 OUS
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96948
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.