DreamStation Auto — Class I medical device recall Z-2229-2025
Ongoing recall by Philips Respironics, Inc., reported 2025-08-20, distributed nationwide. Devices may possess a programming error resulting in an incorrect device configuration.
| Recall number | Z-2229-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2025-06-30 |
| Classified | 2025-08-08 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Quantity | 28 units |
| UPC / GTIN / UDI-DI | 00195817171415, 00255220797791, 00262274772766, 00606959069824 |
| Serial numbers | J19093383C0FD, J195817171415, J195967969739, J1999161223D4, J208714453211, J21638786344A, J216718740A24, J22792026797C, J23016752559D, J23025544A4CA, J235207601E36, J236974697023, J24378890CB57, J24404277EDBB, J251606314EAA, J255220797791, J25755126C4A9, J262274772766, J26263484C9C9, J26377226BCF1, J26525214B253, J2661985603DE, J26673715FBD4, J27099876ED61, J272180530173 and 3 more |
| Model numbers | UFRX500S14 |
Product
DreamStation Auto. Non-Continuous Ventilator.
Reason for recall
Devices may possess a programming error resulting in an incorrect device configuration.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2229-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.