HIGH

Philips Respironics Trilogy Evo O2 Ventilator Recall Covers 113,717 Units Worldwide (2026)

Philips Respironics recalled 113,717 Trilogy Evo O2 home-use ventilators worldwide on March 2, 2026 after determining that using non-pneumatic nebulizers with the device can cause a mismatch between the set tidal volume and the delivered tidal volume. The defect could lead to under- or over-ventilation with serious health consequences. Stop using the device immediately and follow the recall steps.

Quick Facts at a Glance

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

Hazard Information

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.

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 O2 is a home-use ventilator. It is used to support patients who require mechanical ventilation outside a hospital setting. Philips Respironics issued this recall to address a compatibility issue with certain nebulizers.

Why This Is Dangerous

Using non-pneumatic nebulizers with the Trilogy Evo platform may cause a mismatch between the set tidal volume and the actual tidal volume delivered to the patient, creating a ventilation risk.

Industry Context

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

Real-World Impact

The recall could require urgent device cessation for affected patients and prompts medical oversight to avoid potential under- or over-ventilation.

Practical Guidance

How to identify if yours is affected

  1. Verify device is Trilogy Evo O2
  2. Check software version is 1.05.15.00
  3. Confirm use of non-pneumatic nebulizers with the device
  4. Look for recall notification from Philips or the FDA notice linked above

Where to find product info

Official recall notice and guidance are available through the FDA enforcement page referenced in the recall notice and Philips Respironics communications.

What timeline to expect

Refunds or replacements are typically resolved within 4-8 weeks after recall initiation, depending on Philips’ procedures.

If the manufacturer is unresponsive

  • Document all communication attempts
  • Contact your healthcare provider for interim guidance
  • File a complaint with the appropriate medical-device regulator if the manufacturer is unresponsive

How to prevent similar issues

  • Verify nebulizer compatibility with the Trilogy Evo O2 platform before use
  • Rely only on nebulizers approved by the manufacturer
  • Monitor for recall notices and follow manufacturer instructions promptly
  • Keep manufacturer recall contact information readily available

Documentation advice

Keep a copy of the recall notice, serial/UDI numbers, dates, and all correspondence with the manufacturer and your clinician.

Product Details

Brand: Philips Respironics. Product: Trilogy Evo O2 Ventilator. Software Version: 1.05.15.00. Models: All Model No., All UDI, All Serial No. Sold at: Worldwide distribution including US nationwide and numerous foreign markets. Sold since: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 113,717 total units affected
  • Global distribution across the US and other countries
  • No injuries or incidents reported to date
  • Recall date: 2026-03-02

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 LevelCRITICAL
Severity Score
9/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeHome-use Ventilator
Sold At
Multiple Retailers

Product Details

Model Numbers
All Model No.
All UDI
All Serial No.
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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