HIGH

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

Philips Respironics recalled 113,717 Trilogy Evo Universal ventilators worldwide on March 2, 2026. The recall cites a condition where using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the delivered tidal volume. Patients and caregivers should stop using the device immediately and contact Philips Respironics or their healthcare provider for instructions.

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, PREGNANT, ELDERLY

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 Universal is a home-use ventilator platform used to manage patients with respiratory failure. It relies on nebulized medication delivery, typically through nebulizers, as part of the treatment plan.

Why This Is Dangerous

Using non-pneumatic nebulizers with Trilogy Evo may cause a mismatch between the intended tidal volume and the actual tidal volume delivered to the patient, potentially impairing ventilation.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall centers on a life-sustaining device. Stop-use instructions must be followed to prevent potential respiratory compromise while awaiting further guidance.

Practical Guidance

How to identify if yours is affected

  1. Verify device is Trilogy Evo Universal.
  2. Check software version 1.05.15.00.
  3. Confirm use of non-pneumatic nebulizers with the device.

Where to find product info

FDA recall page and Philips Respironics recall notices.

What timeline to expect

Remedy or replacement timelines will be provided by Philips; typical recall processes may take weeks.

If the manufacturer is unresponsive

  • Document all attempts to contact Philips and your healthcare provider.
  • Contact FDA or local health authority if you cannot obtain guidance.
  • Consider legal counsel if a delay results in harm.

How to prevent similar issues

  • Do not use non-pneumatic nebulizers with Trilogy Evo until cleared by a clinician.
  • Monitor for signs of inadequate ventilation such as increased work of breathing or hypoxia.
  • Keep the recall notice and serial/identification information for your records.

Documentation advice

Keep recall letters, communications with Philips, dates of inquiries, and any symptom reports; document device serial numbers and software version.

Product Details

Model numbers: All Model No., All UDI, All Serial No. Where sold: Worldwide distribution; US nationwide; numerous countries listed When sold: Not specified Price: Not specified

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 113,717 units recalled
  • Global distribution including US nationwide
  • Software version 1.05.15.00
  • Non-pneumatic nebulizers implicated
  • No injuries reported to date
  • Follow manufacturer recall instructions

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
GENERALPREGNANTELDERLYPREGNANTINFANTSCHILDRENPETS
Injury Types
SUFFOCATIONELECTRICALOTHER

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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