Use cautionMedical device recall · FDA · Published December 22, 2021
Philips Respironics Trilogy Evo Ventilator Recall: Non-conforming foam may cause
Philips Respironics recalls Trilogy Evo ventilators with specific material numbers due to non-conforming sound abatement foam that may degrade into particles and be inhaled by users.
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.
“Philips Respironics Trilogy Evo Ventilator Recall: Non-conforming foam may cause.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61371-philips-respironics-trilogy-evo-ventilator-recall-non-conforming-foam-may. Based on FDA recall #Z-0493-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0493-2022%22&limit=1).
The FDA announced on December 22, 2021, that Philips Respironics, Inc. is recalling Trilogy Evo ventilators due to non-conforming foam that may degrade and be inhaled by users. The recall affects 473 devices distributed worldwide. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Philips Respironics
Product: Trilogy Evo ventilator
Material Numbers: DS2110X11B (USA), KR2110X15B (Korea)
A supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam in the devices. This non-conforming material may degrade into particles that enter the air pathway and be ingested or inhaled by the user. The foam may also off-gas chemicals during initial use.
Context
GovInfoNow's records show Philips Respironics, Inc. has issued 25 other recalls since June 12, 2018. Recent recalls include a March 2, 2026 Trilogy Evo software issue where the obstruction alarm may fail and another on the same date involving tidal volume discrepancy risks. Other recent recalls of similar products include a March 25, 2026 Ventec V+Pro ventilator oxygen leak risk and an February 18, 2026 Baxter Blue ventilator adapter module oxygen desaturation risk.
How to tell if you have this one
Check for the material numbers DS2110X11B (USA) or KR2110X15B (Korea) on the ventilator. The product identifiers (serial numbers) listed in the recall include many specific codes starting with H312, H296, H3122, etc.
Brand
Philips Respironics
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
Worldwide Distribution: Distributed to the following US states: AR, CO, FL, IA, IL, KY, LA, MI, MT, OH, PA, TN, TX, UT, VA, WV, and WY; and Distributed to the following foreign countries: Argentina, Brazil, Romania, and Netherlands.
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.; Lot Numbers 210414 - 210524
205 kits
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Look for the product identifier (serial number) on the ventilator to see if it matches the listed codes.
Contact Philips Respironics
If the device is affected, contact Philips Respironics for instructions on how to return or replace the device.
Where it went and when
Where it was distributed
Distributed in 17 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Worldwide Distribution: Distributed to the following US states: AR, CO, FL, IA, IL, KY, LA, MI, MT, OH, PA, TN, TX, UT, VA, WV, and WY; and Distributed to the following foreign countries: Argentina, Brazil, Romania, and Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0493-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0493-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.