Is my Trilogy Evo Universal ventilator recalled?

If your device is a Trilogy Evo Universal with software version 1.05.15.00, it may be affected. The recall covers all model numbers, UDIs and serial numbers. Check the documentation for the recall number Z-1649-2026 on the FDA site.

What is the hazard of this recall?

The obstruction alarm may not trigger within the required timeframe. Warning could be delayed by up to four breaths, potentially impacting patient safety.

How many units are recalled?

113,717 units are part of the recall. Distribution includes nationwide U.S. and many international markets.

What should I do right now?

Stop using the device immediately. Follow the recall instructions from Philips Respironics or your healthcare provider for next steps.

Will the device be repaired or replaced?

Remedies may include repair or replacement as directed by Philips Respironics. Follow the official recall guidance for next steps.

Where can I find more information?

Refer to the FDA enforcement page for this recall and Philips Respironics’ official communication channels.

Are international locations affected?

Yes. The recall lists multiple countries beyond the United States, including Argentina, Austria, Australia and many others.

What constitutes safe action during the recall?

Do not continue using the affected ventilator. Contact your healthcare provider for guidance and do not attempt to modify the device yourself.

How will I know if my device is affected?

Manufacturers typically identify affected units by model numbers, UDIs and serial numbers. In this recall, all Model No., UDI and Serial No. entries are included.

How long may the recall process take?

The recall notification details do not specify a precise timeline for replacement or repair. Follow manufacturer instructions and monitor the FDA page for updates.

What should caregivers do?

Follow the same steps: stop use, contact Philips Respironics or the patient’s provider, and await replacement or repair instructions.

What documentation should I keep?

Keep recall notices, communications with Philips Respironics, and records of any device identifiers and replacement or repair actions.

HIGHMarch 2, 2026

Philips Respironics Trilogy Evo Universal Ventilator Recall 113,717 Units (2026)

Philips Respironics recalled 113,717 Trilogy Evo Universal home-use ventilators sold by multiple retailers after alarms may fail to trigger. The obstruction alarm may not trigger within the required timeframe, delaying warning by up to four breaths. Patients should stop using the device and follow the manufacturer’s recall instructions or contact their healthcare provider for guidance.

Quick Facts at a Glance

Recall Date: March 2, 2026
Hazard Level: HIGH
Brand: Philips Respironics
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Respironics, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Trilogy Evo Universal is a continuous home-use ventilator designed to assist patients with breathing support at home. It is used under medical supervision and typically prescribed for respiratory failure or chronic conditions.

Why This Is Dangerous

The obstruction alarm failure means the device may not alert users to an airway obstruction promptly. This can delay intervention during obstructed breaths and increases risk to patients relying on the device for breathing support.

Industry Context

This recall is not identified as part of a broader industry pattern in the provided data.

Real-World Impact

The recall creates a potential safety risk for patients using the device at home or in care settings. The scale is large, and the issue could disrupt essential therapy while awaiting remedy.

Practical Guidance

How to identify if yours is affected

Verify if your device is a Trilogy Evo Universal with software version 1.05.15.00.
Check for model numbers, UDIs and serial numbers; the recall covers all Model No., All UDI and All Serial No.
Compare against the recall notice and the FDA page for Z-1649-2026.

Where to find product info

Refer to the FDA enforcement recall page and Philips Respironics’ official recall communications for identification numbers and instructions.

What timeline to expect

The public timeline for refunds or replacements is not specified in the data provided.

If the manufacturer is unresponsive

Escalate to consumer protection agencies if there is no timely response.
Document all communications with Philips Respironics.

How to prevent similar issues

When buying home-use ventilators, verify recall status and software version compatibility.
Register devices with the manufacturer to receive recall alerts.
Look for certifications and ensure a clear recall pathway with a designated contact.

Documentation advice

Keep copies of the recall notice, product identifiers, communications with the manufacturer, and records of any replacement or repair actions.

Product Details

Brand: Philips Respironics; Product: Trilogy Evo Universal Continuous Home-Use Ventilator; Software Version: 1.05.15.00; Model numbers: All Model No., All UDI, All Serial No.; Sold domestically Nationwide; Sold internationally in listed countries; Recall Date: 2026-03-02; Remedy: Stop using the device and follow recall instructions from Philips Respironics or healthcare provider; Classification: Class I; Quantity: 113,717 units; Status: Active; Source: FDA enforcement page (Z-1649-2026).

Reported Incidents

No injuries or incidents have been reported.

Key Facts

113,717 units recalled
Global distribution includes the United States and a long list of international markets
Obstruction Alarm may not trigger within safety-standard timeframes
Delay could be up to four breaths

View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

SUFFOCATIONELECTRICAL

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeHome-use Ventilator

Product Details

Mar 2, 2026

Philips Respironics

In some