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 8, 2026
RecallRadar source check
April 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
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 providing respiratory support for patients with chronic respiratory insufficiency. It is marketed for ongoing daily use under clinician supervision.
Why This Is Dangerous
A delay in triggering the obstruction alarm can leave a patient without timely warning of airway obstruction. This can prolong unsafe breathing conditions and pose a risk to life if not addressed.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Patients and caregivers must stop using the affected devices until advised. The interruption of ventilation support can have serious safety and health consequences and may require medical supervision and alternative arrangements.
Practical Guidance
How to identify if yours is affected
- Confirm device is Trilogy Evo O2 with software version 1.05.15.00.
- Check device label or system menu for software version.
- Cross-check with the recall notice and FDA page (Z-1647-2026).
Where to find product info
Recall letter, Philips Respironics patient guidance, and FDA enforcement page provided above.
What timeline to expect
Remedy processing and replacement or guidance typically take 4-8 weeks, depending on the program.
If the manufacturer is unresponsive
- Escalate with your healthcare provider, contact Philips Respironics consumer support, and file a complaint with the U.S. FDA if necessary.
- Document all communications and keep the recall letter for reference.
How to prevent similar issues
- Regularly check software updates from the manufacturer.
- Only operate ventilators under clinician guidance.
- Maintain backup ventilation plans and power sources.
- Ensure contact information for Philips Respironics is current for recall alerts.
Documentation advice
Keep the recall letter, purchase records, device serial number and model information, and any correspondence with Philips Respironics or healthcare providers.
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Product Details
Product: Philips Respironics Trilogy Evo O2 home-use ventilator. Software version: 1.05.15.00. Recall quantity: 113,717 units. Model numbers: All Model No., All UDI, All Serial No. Sold nationwide in the United States and distributed internationally to many countries (Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, and more). Recall date: 2026-03-02. Recall status: Active.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 113,717 units recalled worldwide
- Software Version 1.05.15.00 involved
- Obstruction Alarm delay up to four breaths
- Domestic nationwide distribution; broad international outreach
- Recall date 2026-03-02; Status Active
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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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