What device is recalled?

The Philips Respironics Trilogy EV300 ventilator with software version 1.05.15.00 is recalled. The recall covers 113,717 units distributed domestically and internationally.

The Obstruction Alarm may not trigger within required standards and may delay alerts for up to four breaths, potentially impacting patient safety.

How many units are affected?

113,717 units are covered by this recall across domestic and international markets.

Who is affected by the recall?

Patients and healthcare providers using the Trilogy EV300 ventilator in homes and clinical settings.

When was the recall issued?

Recall date is March 2, 2026. The enforcement report was updated on April 8, 2026.

What should I do if I own this device?

Stop using the device immediately. Contact Philips Respironics or your healthcare provider for instructions and follow the recall notice.

Will I receive a refund or replacement?

The remedy directs contacting Philips Respironics for instructions on refunds or replacements. Specific timelines and terms are provided in the recall notice.

Have there been any injuries or deaths?

No injuries or incidents have been reported in the information provided.

Where can I get more information?

Refer to the FDA enforcement page for recall details and Philips support resources.

How do I identify if my device is affected?

Check the device label for Trilogy EV300 and software version 1.05.15.00. The recall covers all Trilogy EV300 units with that software version.

What should I do with the device after stopping use?

Do not discard the device unless instructed. Await guidance from Philips Respironics or your clinician.

What if I cannot reach Philips?

Document attempts to contact and consult your healthcare provider. You can also seek guidance from local health authorities.

How long will refunds or replacements take?

The recall guidance notes processing timelines will be provided by Philips Respironics; typical timelines are defined in the recall notice.

HIGHMarch 2, 2026

Philips Respironics Trilogy EV300 Ventilator Recall Affects 113,717 Units in 2026

Philips Respironics recalled 113,717 Trilogy EV300 ventilators sold in the United States and internationally after determining the Obstruction Alarm may fail to trigger within required standards. The alarm can delay alerting caregivers for up to four breaths. Patients and healthcare providers should stop using the device immediately and follow recall instructions from Philips or their clinician.

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 EV300 is a home-use ventilator designed to provide mechanical ventilation for patients needing respiratory support at home or in clinical settings. It is used under medical supervision and in conjunction with patient care plans.

Why This Is Dangerous

The Obstruction Alarm failure means the device may not alert caregivers promptly during an obstruction event. If the alarm is delayed by up to four breaths, patients could experience reduced monitoring during critical moments.

Industry Context

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

Real-World Impact

Patients relying on the device risk delayed alerts during obstruction events. Immediate cessation of use and clinician consultation are advised to prevent potential harm.

Practical Guidance

How to identify if yours is affected

Verify device is Trilogy EV300 with software version 1.05.15.00
Check device label for model and software version
Confirm quantity in household or facility is part of the 113,717 recall
Review recall letter from Philips or FDA page to confirm next steps

Where to find product info

Recall documentation and guidance available from Philips Respironics andFDA enforcement page linked in recall notice

What timeline to expect

Refunds or replacements will follow Philips recall guidance; processing times are not specified in the provided data

If the manufacturer is unresponsive

Document all contact attempts
Escalate to healthcare provider or regulator if Philips is unresponsive
Consider filing a report with the FDA if safety concerns persist

How to prevent similar issues

Always check for recalls before deploying medical devices at home
Register for recall notifications from device manufacturers
Keep firmware/software up to date where the manufacturer approves and documents updates
Consult clinicians before replacing devices with non-approved models

Documentation advice

Keep the recall letter, photos of device label, original purchase information, and all correspondence with Philips or healthcare providers

Product Details

• Product: Trilogy EV300 Ventilator • Software Version: 1.05.15.00 • Manufacturer: Philips Respironics • Sold to: Hospitals, clinics, and home-health providers • Domestic distribution: Nationwide • Foreign distribution: Argentina, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Italy, Japan, Mexico, the Netherlands, Spain, United Kingdom, and more • Model numbers: Trilogy EV300; Software Version 1.05.15.00 • Price: Unknown • Quantity: 113,717 units

Reported Incidents

No injuries or incidents have been reported.

Key Facts

113,717 units recalled
Obstruction Alarm may delay alerts by up to 4 breaths
Recall issued 2026-03-02; report date 2026-04-08
Active recall with nationwide and international distribution

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

SUFFOCATION

Product Classification

CategoryHealth & Personal Care › Respiratory Equipment

Product TypeVentilator

Product Details

Mar 2, 2026

Philips Respironics

Using non-pneumatic