Philips Respironics, Inc.

Devices and FDA recall records listed on MedWatcher for Philips Respironics, Inc..

What MedWatcher tracks

This page covers the devices and recall records listed below, not the complete product catalogue or recall history. A recall may apply only to specific models, lots, or serial numbers.

Tracked devices: 1
Recall records: 4
Source records last checked: Oct 27, 2026

Manufacturer names

Device and manufacturer names are linked using official product, UDI, or FDA records. The source links below show the supporting information.

Official records may use a legal name, brand, division, or shortened name. Similar names do not necessarily refer to the same manufacturer.

Philips Respironics, Inc.Source-name variantOfficial source (opens in a new tab)

Sources used for this page

U.S. Food and Drug Administration Global Unique Device Identification DatabaseDreamStation 2 device identifier recordLast checked Aug 16, 2026 U.S. Food and Drug AdministrationFDA medical device recall event 96948Last checked Aug 16, 2026 U.S. Food and Drug AdministrationFDA medical device recall event 97191Last checked Aug 16, 2026

Sleep apnea therapy devices

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Philips DreamStation 2 PAP System

Philips Respironics, Inc. · Sleep apnea therapy devices

No linked recall records

Latest source check Oct 8, 2026

Recent recall records

Class I recallOngoing

Philips Respironics Trilogy Evo recall — FDA event 98540

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

FDA · FDA event 98540Posted Apr 2, 2026

Class I recallOngoing

Philips Respironics Trilogy Evo recall — FDA event 98537

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

FDA · FDA event 98537Posted Mar 26, 2026

Class I recallOngoing

DreamStation Auto recall — FDA event 97191

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

FDA · FDA event 97191Posted Aug 8, 2025

Class I recallOngoing

BiPAP A40 Ventilator recall — FDA event 96948

This device does not indicate for use in patients with respiratory failure.

FDA · FDA event 96948Posted Jul 2, 2025

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Recent recall records

Class I recallOngoing

Philips Respironics Trilogy Evo recall — FDA event 98540

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

FDA · FDA event 98540Posted Apr 2, 2026

Class I recallOngoing

Philips Respironics Trilogy Evo recall — FDA event 98537

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

FDA · FDA event 98537Posted Mar 26, 2026

Class I recallOngoing

DreamStation Auto recall — FDA event 97191

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

FDA · FDA event 97191Posted Aug 8, 2025

Class I recallOngoing

BiPAP A40 Ventilator recall — FDA event 96948

This device does not indicate for use in patients with respiratory failure.

FDA · FDA event 96948Posted Jul 2, 2025

Philips Respironics, Inc.

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What MedWatcher tracks

Manufacturer names

Sources used for this page

Sleep apnea therapy devices

Philips DreamStation 2 PAP System

Recent recall records

Philips Respironics Trilogy Evo recall — FDA event 98540

Philips Respironics Trilogy Evo recall — FDA event 98537

DreamStation Auto recall — FDA event 97191

BiPAP A40 Ventilator recall — FDA event 96948

Philips Respironics, Inc.

Follow Philips Respironics, Inc.

What MedWatcher tracks

Manufacturer names

Sources used for this page

Sleep apnea therapy devices

Philips DreamStation 2 PAP System

Recent recall records

Philips Respironics Trilogy Evo recall — FDA event 98540

Philips Respironics Trilogy Evo recall — FDA event 98537

DreamStation Auto recall — FDA event 97191

BiPAP A40 Ventilator recall — FDA event 96948