LifeVent EVO2 — Class I medical device recall Z-0296-2025
Ongoing recall by Philips Respironics, Inc., reported 2024-11-20, distributed nationwide. Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation o
| Recall number | Z-0296-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2024-10-07 |
| Classified | 2024-11-13 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 1,244 units |
| UPC / GTIN / UDI-DI | 00606959057456 |
| Model numbers | SP2100X26B |
Product
LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Reason for recall
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
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-0296-2025. 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.