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Use caution Medical device recall · FDA · Published June 14, 2021

Philips Respironics Trilogy Ventilators Recall: PE-PUR Foam May Cause Ingestion

Philips Respironics recalls Trilogy 100, 200, Garbin Plus, Aeris, and LifeVent ventilators made before April 2021 due to potential PE-PUR foam particles entering air pathways and being inhaled or ingested by users.

🇺🇸 FDA recall #Z-1956-2021Medical devicePhilips Respironics ›
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Recalling firmPhilips Respironics, Inc.1001 Murry Ridge Ln · Murrysville, PA 15668-8517
✎ GovInfoNow plain-language explainer

Philips Respironics is recalling several continuous ventilator models made before April 2021 because the foam used in their construction could break into particles that users might inhale or ingest. This poses a health risk, especially for people who rely on these devices for breathing support. Read more at govinfonow.com/recall/62337-philips-respironics-trilogy-ventilators-recall-pe-pur-foam-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/62337-philips-respironics-trilogy-ventilators-recall-pe-pur-foam-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1956-2021

Cite this page

“Philips Respironics Trilogy Ventilators Recall: PE-PUR Foam May Cause Ingestion.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62337-philips-respironics-trilogy-ventilators-recall-pe-pur-foam-may-cause. Based on FDA recall #Z-1956-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1956-2021%22&limit=1).

The FDA announced on June 14, 2021, that Philips Respironics is recalling Trilogy 100, Trilogy 200, Garbin Plus, Aeris, and LifeVent continuous ventilators. The recall addresses a hazard where degrading foam may release particles or chemicals into the user's airway.

How to tell if you have it

  • Brand: Philips Respironics
  • Products: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators
  • Manufacture Date: All devices manufactured before April 26, 2021
  • Material Numbers: 1040001, 1054096, 1054097, 1054260, 1054655, 1058180, 1119867, 1040001B, 1054096B, 1054096NB, 1054097B, 1054260B, 1054655B, 1054655TP, 1054655TPV, 1058180B, AU1054096, AU1054096B, BR1054096, BT1054096, BT1054260, CA1054096, CA1054096B, CN1054096, IT1054096B, KO1054096, KR1054096, LA1054096, LG1054096, R1054096, R1054096B, R1054097, R1054097B, R1054260, R1054260B, R1054655, R1054655B, R1054655TP, R1054655TPV, R1119867, RSL1054260, RSL1054260B, RTO1054260, RTO1054260B, U1054096, U1054096B, U1054097, U1054097B, U1054260, U1054260B, U1054655, RBR1054096, RTO1119867, 1032800, 1032802, 1032804, 1040002, 1040005, 1032800B, 1032802B, 1032804B, 1032804TP, 1032804TPV, 1040002B, 1040005B, 1125564B, AU1032800, AU1032800B, BR1032800, CA1032800, CA1032800B, IT1032800B, KO1032800, KR1032800, LA1032800, LG1032800, R1032800, R1032802, R1032804, R1032804B, R1032804TP, R1032804TPV, R1040005, R1040005B, RTO1040005B, SP1032800B, U1032800, U1032802, U1032804, U1040005, U1040005B

The hazard

According to the FDA, the polyester-based polyurethane foam may degrade into particles that could enter the device's air pathway and be ingested or inhaled by the user. The record also states that the foam may off-gas certain chemicals.

Context

GovInfoNow's records show Philips Respironics has had 25 other recalls since June 12, 2018. Recent recalls include a March 2, 2026 Trilogy Evo software issue regarding tidal volume discrepancy and obstruction alarm failure, and an Oct. 7, 2025 SimplyGo Mini battery kit recall for defective chips causing oxygen shutdown. Other recent recalls of similar products include the Ventec V+Pro Ventilator Recall (March 25, 2026), the Baxter Blue Ventilator Adapter Module Recall (Feb. 18, 2026), and the ResMed Astral Ventilators Recall (June 25, 2026).

How to tell if you have this one

Check if your ventilator model is listed in the product names (Trilogy 100, Trilogy 200, Garbin Plus, Aeris, or LifeVent) and was manufactured before April 2021. Look for specific serial numbers or material numbers in the provided list.

  • Brand
    Philips Respironics
  • Category
    Medical device
FDA recall event · 3 products

All 3 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 including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.
Recall numberProduct, codes & lotsQuantity
Z-1956-2021Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.; All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1040001 1054096 1054097 1054260 1054655 1058180 1119867 1040001B 1054096B 1054096NB 1054097B 1054260B 1054655B 1054655TP 1054655TPV 1058180B AU1054096 AU1054096B BR1054096 BT1054096 BT1054260 CA1054096 CA1054096B CN1054096 IT1054096B KO1054096 KR1054096 LA1054096 LG1054096 R1054096 R1054096B R1054097 R1054097B R1054260 R1054260B R1054655 R1054655B R1054655TP R1054655TPV R1119867 RSL1054260 RSL1054260B RTO1054260 RTO1054260B U1054096 U1054096B U1054097 U1054097B U1054260 U1054260B U1054655 RBR1054096 RTO1119867 1032800 1032802 1032804 1040002 1040005 1032800B 1032802B 1032804B 1032804TP 1032804TPV 1040002B 1040005B 1125564B AU1032800 AU1032800B BR1032800 CA1032800 CA1032800B IT1032800B KO1032800 KR1032800 LA1032800 LG1032800 R1032800 R1032802 R1032804 R1032804B R1032804TP R1032804TPV R1040005 R1040005B RTO1040005B SP1032800B U1032800 U1032802 U1032804 U1040005 U1040005B255810
Z-1957-2021A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use; All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1111181 1111182 1111178 1140184 1135427 11436718047
Z-1958-2021A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting; All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1076492 1076493 1076495 1076538 1076539 1076565 1076566 1076579 1076580 1076583 1076584 1076586 1078226 1078297 1104171 1111168 1111169 1111170 1111171 1111172 1111173 1111174 1111175 1111176 1111177 1116156 1122129 1140798 1140799 1111170S 1111170-S AR1111169 BR1076493 BR1076566 BR1111169 CN1076493 CN1076566 CN1111169 GB-SPK0011 GB-SPK0012 IT1111169 LA1076493 LA1076566 R1076495 R1111169 R1111177 R1116156 1104170 R1111175 RBR1111169 U1116156 1038916 1038917 1040716 1044114 1044235 1038987 1040717 1068942 1068943 1042900 1042901 1042903 1042904 1042906 1042907 1044288 1044289 1040718 1067255 1029744 1029750 1029756 1029757 1029758 1029759 AU1029756 CA1029756 CA1029759 LA1029756 1030075 1055770 105581372665
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Identify your ventilator model from the list of affected products: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, or LifeVent.

  2. Verify Manufacturing Date

    Confirm your device was manufactured before April 2021 by checking the serial number or material numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 37 days after the firm started it.

1. Firm started the recall: Jun 14, 202112. FDA classified it Class I: Jul 15, 202123. Published in FDA’s Enforcement Report: Jul 21, 202132021
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-1956-2021 (June 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1956-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA