Philips Respironics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2228-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

DreamStation Auto BiPAP. Non-Continuous Ventilator.

Product Classification:

Class I

Date Initiated: June 30, 2025

Date Posted: August 20, 2025

Recall Number: Z-2228-2025

Event ID: 97191

Reason for Recall:

Devices may possess a programming error resulting in an incorrect device configuration.

Status: Ongoing

Product Quantity: 8 units

Code Information:

Model No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated