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 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 is a home-use ventilator designed to support patients who require assisted breathing. It is used in life-sustaining settings under clinician guidance.
Why This Is Dangerous
The device’s obstruction alarm may fail to alert caregivers within required timeframes, potentially delaying response to airway obstruction.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
The recall creates a safety urgency for patients relying on this device. Immediate cessation of use is advised until instructions from Philips Respironics are provided.
Practical Guidance
How to identify if yours is affected
- Confirm the device is a Philips Respironics Trilogy Evo with software version 1.05.15.00.
- Check the recall notice you received by mail or consult the FDA notice for details.
- Review serial numbers and model information to determine applicability (the notice lists all models).
Where to find product info
FDA recall enforcement page: recell_number=Z-1646-2026. Official Philips Respironics recall notice.
What timeline to expect
Timelines for refunds or replacements are not specified in the recall notice.
If the manufacturer is unresponsive
- Document all contact attempts with Philips Respironics and your clinician.
- Escalate to patient safety or hospital administration if responses are delayed.
How to prevent similar issues
- Monitor for recalls on Philips and FDA sites for devices in use.
- Coordinate with healthcare providers for safe device replacement options.
- Maintain records of recall communications and device serial numbers.
Documentation advice
Keep recall letter, device identifiers (model/serial/UDI), purchase records, and correspondence with Philips Respironics.
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Product Details
Model numbers: All Model No., All UDI, All Serial No. Where sold: Domestic nationwide distribution; Foreign distribution to numerous countries listed in the recall. When sold: Not specified in the recall notice. Price: Not specified.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Obstruction Alarm may not trigger for up to four breaths
- Global distribution across the U.S. and many international markets
- Remedy requires stopping use and following manufacturer instructions
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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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