FDA Medical devices recall ·
DreamStation Auto BiPAP. Non-Continuous Ventilator recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2228-2025
- 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
- 8 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DreamStation Auto BiPAP. 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. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77.
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-2228-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.