What is being recalled?

Philips Respironics Trilogy Evo ventilators with software version 1.05.15.00 are recalled because the Obstruction Alarm may fail to trigger within required standards, potentially delaying alerting caregivers by up to four breaths.

How many units are affected?

113,717 units are affected worldwide, including domestic and international distribution.

What should I do if I own this device?

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

Has anyone been injured?

No injuries or incidents have been reported in the recall notice.

When was the recall issued?

The recall date is March 2, 2026, and the notification status is active.

Where was the device sold?

Domestic nationwide distribution in the United States and distribution to many countries listed in the recall.

What is the risk if the alarm fails?

If the Obstruction Alarm does not trigger, there could be delayed recognition of airway obstruction, compromising patient safety.

Will I get a refund or replacement?

The recall notice directs following manufacturer instructions for remedy; specifics on refunds or replacements are provided by Philips Respironics.

Where can I find the recall notice?

The FDA enforcement page referenced in the recall provides official details and instructions.

Who should I contact for help?

Contact Philips Respironics or your healthcare provider for guidance on next steps.

Is this recall limited to a particular country?

Distribution is nationwide in the U.S. and includes numerous international markets.

What is the software version involved?

Software version 1.05.15.00 is the version cited in the recall.

HIGHMarch 2, 2026

Philips Respironics Trilogy Evo Ventilator Recall 2026 Affects 113,717 Units

Philips Respironics recalled 113,717 Trilogy Evo home-use ventilators worldwide after finding the Obstruction Alarm may fail to trigger, potentially delaying alerts by up to four breaths. The devices were distributed nationwide in the United States and internationally. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions.

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 is a home-use ventilator designed to support patients who require assisted breathing. It is used in life-sustaining settings under clinician guidance.

Why This Is Dangerous

The device’s obstruction alarm may fail to alert caregivers within required timeframes, potentially delaying response to airway obstruction.

Industry Context

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

Real-World Impact

The recall creates a safety urgency for patients relying on this device. Immediate cessation of use is advised until instructions from Philips Respironics are provided.

Practical Guidance

How to identify if yours is affected

Confirm the device is a Philips Respironics Trilogy Evo with software version 1.05.15.00.
Check the recall notice you received by mail or consult the FDA notice for details.
Review serial numbers and model information to determine applicability (the notice lists all models).

Where to find product info

FDA recall enforcement page: recell_number=Z-1646-2026. Official Philips Respironics recall notice.

What timeline to expect

Timelines for refunds or replacements are not specified in the recall notice.

If the manufacturer is unresponsive

Document all contact attempts with Philips Respironics and your clinician.
Escalate to patient safety or hospital administration if responses are delayed.

How to prevent similar issues

Monitor for recalls on Philips and FDA sites for devices in use.
Coordinate with healthcare providers for safe device replacement options.
Maintain records of recall communications and device serial numbers.

Documentation advice

Keep recall letter, device identifiers (model/serial/UDI), purchase records, and correspondence with Philips Respironics.

Product Details

Model numbers: All Model No., All UDI, All Serial No. Where sold: Domestic nationwide distribution; Foreign distribution to numerous countries listed in the recall. When sold: Not specified in the recall notice. Price: Not specified.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

113,717 units recalled
Software version 1.05.15.00
Obstruction Alarm may not trigger for up to four breaths
Global distribution across the U.S. and many international markets
Remedy requires stopping use and following manufacturer instructions

View Original Recall on FDA - Medical Devices

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

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

ELECTRICALOTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeHome Ventilator

Product Details

Brand

Philips Respironics

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