Trilogy EV300 ventilator recalled as Class I over tidal volume
Philips Respironics is recalling the Trilogy EV300 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
Philips Respironics, Inc. is recalling the Philips Respironics Trilogy EV300, software version 1.05.15.00, a continuous home-use ventilator. About 113,717 units were distributed worldwide, covering the United States nationwide and more than eighty other countries.
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. The FDA has classified this recall as Class I, its most serious category.
All model numbers, UDIs and serial numbers are affected.
Facilities and users can identify affected devices by the software version above, and may contact Philips Respironics, Inc. for further information.
The recalled product
- Product
- Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 113,717
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All Model No.
- All UDI
- All Serial No.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Philips Respironics, Inc.
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FDA (Devices) · 2026-04-08
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- SevereTrilogy Evo Universal obstruction alarm may take up to four breaths
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- SevereTrilogy Evo O2 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo ventilator recalled as Class I over tidal volume
FDA (Devices) · 2026-04-01
Same hazard · tidal volume discrepancy
See all →- SevereTrilogy Evo O2 ventilator recalled as Class I over tidal volume
FDA (Devices) · 2026-04-01
- SevereTrilogy Evo Universal ventilator recalled as Class I over tidal volume
FDA (Devices) · 2026-04-01