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
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 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
- Verify device is Trilogy Evo O2
- Check software version is 1.05.15.00
- Confirm use of non-pneumatic nebulizers with the device
- 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.
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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
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Safety Guide
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