Philips Respironics, Inc. recalls Philips Respironics Trilogy EV300

Recalling company

Philips Respironics, Inc.

Product

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Reason

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.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Mar 2, 2026

Reported

Apr 1, 2026

Distribution

Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Georgia, French Guiana, Gibraltar, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jersey, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Montenegro, North Macedonia, Myanmar, Martinique, Malta, Mexico, Malaysia, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, French Polynesia, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, R¿union, Romania, Serbia, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Vietnam, Mayotte, South Africa, Zimbabwe.

Status

Ongoing

Quantity

113,717 units

Lot / codes

All Model No.; All UDI; All Serial No.

Company location

Murrysville, PA

Recall type

Voluntary: Firm initiated

Recall number

Z-1616-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1616-2026 in the FDA Enforcement Report. Also see FDA recall press releases.