Quick Facts at a Glance
- Recall Date
- March 2, 2026
- Hazard Level
- HIGH
- 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 Universal is a continuous home-use ventilator designed to assist patients with breathing support at home. It is used under medical supervision and typically prescribed for respiratory failure or chronic conditions.
Why This Is Dangerous
The obstruction alarm failure means the device may not alert users to an airway obstruction promptly. This can delay intervention during obstructed breaths and increases risk to patients relying on the device for breathing support.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided data.
Real-World Impact
The recall creates a potential safety risk for patients using the device at home or in care settings. The scale is large, and the issue could disrupt essential therapy while awaiting remedy.
Practical Guidance
How to identify if yours is affected
- Verify if your device is a Trilogy Evo Universal with software version 1.05.15.00.
- Check for model numbers, UDIs and serial numbers; the recall covers all Model No., All UDI and All Serial No.
- Compare against the recall notice and the FDA page for Z-1649-2026.
Where to find product info
Refer to the FDA enforcement recall page and Philips Respironics’ official recall communications for identification numbers and instructions.
What timeline to expect
The public timeline for refunds or replacements is not specified in the data provided.
If the manufacturer is unresponsive
- Escalate to consumer protection agencies if there is no timely response.
- Document all communications with Philips Respironics.
How to prevent similar issues
- When buying home-use ventilators, verify recall status and software version compatibility.
- Register devices with the manufacturer to receive recall alerts.
- Look for certifications and ensure a clear recall pathway with a designated contact.
Documentation advice
Keep copies of the recall notice, product identifiers, communications with the manufacturer, and records of any replacement or repair actions.
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Product Details
Brand: Philips Respironics; Product: Trilogy Evo Universal Continuous Home-Use Ventilator; Software Version: 1.05.15.00; Model numbers: All Model No., All UDI, All Serial No.; Sold domestically Nationwide; Sold internationally in listed countries; Recall Date: 2026-03-02; Remedy: Stop using the device and follow recall instructions from Philips Respironics or healthcare provider; Classification: Class I; Quantity: 113,717 units; Status: Active; Source: FDA enforcement page (Z-1649-2026).
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution includes the United States and a long list of international markets
- Obstruction Alarm may not trigger within safety-standard timeframes
- Delay could be up to four breaths
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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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