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
- Ventilator
- Model numbers
- Trilogy EV300, Software Version 1.05.15.00, 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 EV300 is a home-use ventilator designed to provide mechanical ventilation for patients needing respiratory support at home or in clinical settings. It is used under medical supervision and in conjunction with patient care plans.
Why This Is Dangerous
The Obstruction Alarm failure means the device may not alert caregivers promptly during an obstruction event. If the alarm is delayed by up to four breaths, patients could experience reduced monitoring during critical moments.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Patients relying on the device risk delayed alerts during obstruction events. Immediate cessation of use and clinician consultation are advised to prevent potential harm.
Practical Guidance
How to identify if yours is affected
- Verify device is Trilogy EV300 with software version 1.05.15.00
- Check device label for model and software version
- Confirm quantity in household or facility is part of the 113,717 recall
- Review recall letter from Philips or FDA page to confirm next steps
Where to find product info
Recall documentation and guidance available from Philips Respironics andFDA enforcement page linked in recall notice
What timeline to expect
Refunds or replacements will follow Philips recall guidance; processing times are not specified in the provided data
If the manufacturer is unresponsive
- Document all contact attempts
- Escalate to healthcare provider or regulator if Philips is unresponsive
- Consider filing a report with the FDA if safety concerns persist
How to prevent similar issues
- Always check for recalls before deploying medical devices at home
- Register for recall notifications from device manufacturers
- Keep firmware/software up to date where the manufacturer approves and documents updates
- Consult clinicians before replacing devices with non-approved models
Documentation advice
Keep the recall letter, photos of device label, original purchase information, and all correspondence with Philips or healthcare providers
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Product Details
• Product: Trilogy EV300 Ventilator • Software Version: 1.05.15.00 • Manufacturer: Philips Respironics • Sold to: Hospitals, clinics, and home-health providers • Domestic distribution: Nationwide • Foreign distribution: Argentina, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Italy, Japan, Mexico, the Netherlands, Spain, United Kingdom, and more • Model numbers: Trilogy EV300; Software Version 1.05.15.00 • Price: Unknown • Quantity: 113,717 units
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Obstruction Alarm may delay alerts by up to 4 breaths
- Recall issued 2026-03-02; report date 2026-04-08
- Active recall with nationwide and international distribution
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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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