FDA Medical devices recall ·
DreamStation Auto recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2229-2025
- Date
- (initiated June 30, 2025)
- Company / brand
- Philips Respironics, Inc.
1001 Murry Ridge Ln, Murrysville, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 28 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DreamStation Auto. Non-Continuous Ventilator.
Why was it recalled?
Devices may possess a programming error resulting in an incorrect device configuration.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. UFRX500S14; UDI: 606959069824; Serial No. 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, J27467764497E, J305016887150, J30708300FB50.
Distribution
Worldwide - US Nationwide in the states of AL, CA, CO, FL, GA, IN, LA, MD, NE, NJ, NY, PA, TX & DC. The country of France.
States: Alabama California Colorado District of Columbia Florida Georgia Indiana Louisiana Maryland Nebraska New Jersey New York Pennsylvania Texas
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2229-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.