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 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 EV300 is a continuous home-use ventilator intended to support patients with respiratory failure. It is used under medical supervision, often in home settings or during non-acute care.
Why This Is Dangerous
Using non-pneumatic nebulizers with the Trilogy Evo Platform can cause a mismatch between the set and delivered tidal volumes, potentially compromising ventilation and patient safety.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals and home-care patients may face interruptions in supply or require urgent device replacements, creating safety and care continuity concerns.
Practical Guidance
How to identify if yours is affected
- Verify device is Trilogy EV300.
- Check software version 1.05.15.00 on the device label or system menu.
- Confirm use of non-pneumatic nebulizers with the Evo Platform.
Where to find product info
Recall notices available via FDA enforcement page and Philips Respironics recall communications to healthcare providers.
What timeline to expect
Remedy timelines are not specified in the recall notice.
If the manufacturer is unresponsive
- Escalate to regulatory authorities (FDA) if the manufacturer is slow to respond.
- Document all communications and keep the recall letter or notice.
How to prevent similar issues
- Use only compatible nebulizers specified by Philips.
- Consult healthcare providers before changing nebulizer equipment.
- Monitor patient ventilation and report any unusual symptoms immediately.
Documentation advice
Keep recall letter, model numbers, software version, dates of service, and all correspondence with Philips or healthcare providers.
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Product Details
Model numbers: All Model No., All UDI, All Serial No. Where sold: Worldwide distribution through healthcare distributors When sold: Unknown Price: Unknown (price range not disclosed)
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Non-pneumatic nebulizers implicated
- Tidal volume discrepancy risk
- Worldwide distribution (US and foreign)
- Active recall as of 2026-03-02
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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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