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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Philips Respironics
- Product type
- Home-use ventilator
- Model numbers
- All Model No., All UDI, All Serial No.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 2, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 21, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify device is Trilogy Evo Universal.
- Check software version 1.05.15.00.
- 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.
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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
- Global distribution including US nationwide
- Non-pneumatic nebulizers implicated
- No injuries reported to date
- Follow manufacturer recall instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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