The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-2229-2025·Announced 2025-08-20

Non-continuous ventilators recalled over programming error causing incorrect device configuration

DreamStation Auto non-continuous ventilators are recalled because the devices may carry a programming error resulting in an incorrect device configuration. The FDA classified the action as Class I.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this ventilator programming error as Class I.

Plain-English summary

The DreamStation Auto non-continuous ventilator, model number UFRX500S14, UDI 606959069824, is being recalled. Affected units are identified by the serial numbers listed in the recall notice. The recall covers 28 units, distributed in Alabama, California, Colorado, Florida, Georgia, Indiana, Louisiana, Maryland, Nebraska, New Jersey, New York, Pennsylvania, Texas and the District of Columbia, as well as internationally.

The recall was issued because the devices may possess a programming error resulting in an incorrect device configuration. The FDA classified the action as Class I, its most serious category.

Patients using one of these devices should check the serial number against the recall notice and follow the manufacturer's instructions, and should contact their treating clinician before changing or stopping therapy.

The recalled product

Product
DreamStation Auto. Non-Continuous Ventilator.
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
Hazard
Affected units
28

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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