Quick Facts at a Glance
- Recall Date
- March 2, 2026
- Hazard Level
- HIGH
- Brand
- Philips Respironics
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- Continuous Home-Use Ventilator
- Model numbers
- All Model No., All UDI, All Serial No.
- Sold at
- Unknown
- 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 is a patient-ventilator used at home or in clinical settings to support breathing. It can be used with aerosol therapies via nebulizers.
Why This Is Dangerous
The use of non-pneumatic nebulizers with Trilogy Evo may cause the ventilator to deliver a tidal volume that does not match the configured setting, potentially compromising patient ventilation.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The issue presents a high-risk safety concern for users relying on ventilator support. Immediate action is required to prevent potential under- or over-ventilation.
Practical Guidance
How to identify if yours is affected
- Verify software version 1.05.15.00 on the Trilogy Evo unit
- Confirm if non-pneumatic nebulizers were used with the device
- Check if the device is part of the recalled units (model numbers listed as All Model No./All UDI/All Serial No.)
Where to find product info
Recall notifications from Philips Respironics and the FDA enforcement page. Official instructions will be provided to patients and healthcare providers.
What timeline to expect
Remedies and replacement options will be communicated by Philips Respironics through official channels. Specific timelines are not provided in the raw
If the manufacturer is unresponsive
- Escalate to hospital risk management or biosafety officer
- File a report with the FDA if advised by healthcare provider
- Seek assistance from the facility’s biomedical engineering department
How to prevent similar issues
- Avoid using non-pneumatic nebulizers with Trilogy Evo devices unless specifically approved
- Keep software updated according to manufacturer instructions
- If purchasing a ventilator, verify compatibility with prescribed therapies and consult your clinician
- Only follow recall instructions issued by Philips Respironics or your healthcare provider
Documentation advice
Retain the recall notification letter, document serial numbers, model numbers, software version, and all correspondences with Philips Respironics or healthcare providers.
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Product Details
Brand: Philips Respironics Product: Trilogy Evo ventilator Software version: 1.05.15.00 Model numbers: All Model No., All UDI, All Serial No. Sold worldwide to healthcare providers; US nationwide and international distribution to numerous countries Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution; US nationwide
- Non-pneumatic nebulizers linked to the issue
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Safety Guide
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