The Recall Desk
SevereFDA (Devices)·Z-2227-2025·Announced 2025-08-20

DreamStation Auto CPAP units may hold an incorrect device configuration

DreamStation Auto CPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 57 units are affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.

Plain-English summary

The DreamStation Auto CPAP, a non-continuous ventilator, model number UDSX500S11F, UDI 606959429765, is being recalled. The action covers 57 units, identified by the serial numbers in the recall notice.

The stated reason is that devices may possess a programming error resulting in an incorrect device configuration. The FDA classified the action as Class I, its most serious classification.

Distribution was worldwide, including nationwide in the United States across Alabama, California, Colorado, Florida, Georgia, Indiana, Louisiana, Maryland and Nebraska among other states.

Facilities and patients should identify affected units using the model number, UDI and serial numbers above and follow the instructions issued by the manufacturer.

The recalled product

Product
DreamStation Auto CPAP. Non-Continuous Ventilator.
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
Hazard
Affected units
57

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. UDSX500S11F
  • UDI: 606959429765
  • Serial No. J204432084D03
  • J206957368810
  • J207023218478
  • J21450857096A
  • J219786492F58
  • J222909239F3E
  • J22718022B9D6
  • J22924665CF8A
  • J230303131D07
  • J23148826984B
  • J23307132CC16
  • J2379520271A4
  • J23933071851F
  • J23963189F617
  • J242941498857
  • J243763392C02
  • J24551698A015
  • J247575014664

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 →

Related recalls

Same manufacturer · Philips Respironics, Inc.

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Same hazard · programming error

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