FDA Device recall Z-2037-2025
BiPAP A40 Ventilator
- FDA Device
- Class I
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class I recall of BiPAP A40 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-2037-2025 |
| 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 A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
Reason
This device does not indicate for use in patients with respiratory failure.
Identifiers
| code_info | US: A40 Material No. 1111169 UDI-DI 00606959039476 Serial Numbers V182393118CC9 V21942863DD70 V219429359C22 V2558594874…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 V100864760 |
|---|
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-2037-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.