Trilogy 100 — Class I medical device recall Z-1956-2021
Ongoing recall by Philips Respironics, Inc., reported 2021-07-21, distributed nationwide. The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air path
| Recall number | Z-1956-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2021-06-14 |
| Classified | 2021-07-15 |
| Reported by FDA | 2021-07-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CN, DE, FR, IT, JP, KR |
| Quantity | 255,810 |
Product
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
Reason for recall
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1956-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.