FDA Device recall Z-2035-2025
BiPAP V30 Auto Ventilator
- FDA Device
- Class I
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class I recall of BiPAP V30 Auto Ventilator by Philips Respironics, citing this device does not indicate for use in patients with respiratory failure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2035-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-05-09 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Respironics |
| Distribution | US |
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.
Identifiers
| code_info | Part Number 1111178; UDI: 0060959049635; Serial No. N2068642229E4, N206864244CD2, N206864255D5B, N206864277E49, N206864…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, N20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2035-2025%22
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