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# Philips Respironics Recalls Trilogy Evo Ventilators
- URL: https://www.fdaweb.com/philips-respironics-recalls-trilogy-evo-ventilators-2/
- Published: 2022-01-26T12:00:00.000Z
- Updated: 2026-09-14T17:30:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151012

Philips Respironics has recalled certain Trilogy Evo ventilators due to potential health risks caused by a polyester-based polyurethane sound abatement foam that a supplier incorrectly used in the muffler assembly of the affected devices. The issue was identified during lab testing, according to a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-trilogy-evo-ventilators-potential-health-risks-pe-pur-foam?ref=fdaweb.com). The recalled ventilators were distributed to customers in the U.S. and Korea.  

The notice warns that the foam may break down and potentially enter the device’s air pathway. “If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device,” it says.  

The notice says [Trilogy 100 and 200 ventilators](https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health?ref=fdaweb.com) were previously recalled 6/2021 due to the same foam risk. Other Trilogy models are not affected by the issue and are not being recalled — Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal.  

FDA last year inspected Philips Respironics and issued a [29-page Form FDA-483](https://www.fda.gov/media/154099/download?utm%5Fmedium=email&utm%5Fsource=govdelivery) based on a Class 1 recall follow-up ([see story](https://www.fdaweb.com/fda-hits-philips-with-29-page-483-over-recalled-device/)). The inspection was initiated to assess compliance with regulatory requirements and to investigate concerns about the devices’ sound abatement foam.