Philips Respironics
Philips Respironics appears in FDA public data with 94 recalls — including 80 Class I (most serious) —, 2 510(k) clearances, 16 FDA inspections, and 4 compliance actions on record. Its most recent recall (Z-1615-2026, Class I) was initiated on Mar 2, 2026. Its most recent 510(k) clearance was granted on Jul 31, 2024.
Summary
- Total Recalls
- 94 (80 Class I)
- 510(k) Clearances
- 2
- Inspections
- 16
- Compliance Actions
- 4
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1615-2026 | Class I | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator devi | Mar 2, 2026 |
| Z-1646-2026 | Class I | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. | Mar 2, 2026 |
| Z-1616-2026 | Class I | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator devic | Mar 2, 2026 |
| Z-1648-2026 | Class I | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator devic | Mar 2, 2026 |
| Z-1649-2026 | Class I | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilat | Mar 2, 2026 |
| Z-1617-2026 | Class I | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilat | Mar 2, 2026 |
| Z-1647-2026 | Class I | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator devi | Mar 2, 2026 |
| Z-1614-2026 | Class I | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. | Mar 2, 2026 |
| Z-0481-2026 | Class II | SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold a | Oct 7, 2025 |
| Z-2228-2025 | Class I | DreamStation Auto BiPAP. Non-Continuous Ventilator. | Jun 30, 2025 |
| Z-2229-2025 | Class I | DreamStation Auto. Non-Continuous Ventilator. | Jun 30, 2025 |
| Z-2227-2025 | Class I | DreamStation Auto CPAP. Non-Continuous Ventilator. | Jun 30, 2025 |
| Z-2035-2025 | Class I | BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and ad | May 9, 2025 |
| Z-2036-2025 | Class I | BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric pa | May 9, 2025 |
| Z-2037-2025 | Class I | BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating ad | May 9, 2025 |
| Z-0296-2025 | Class I | LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pedi | Oct 7, 2024 |
| Z-0294-2025 | Class I | Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatr | Oct 7, 2024 |
| Z-0293-2025 | Class I | Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B | Oct 7, 2024 |
| Z-0291-2025 | Class I | Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B | Oct 7, 2024 |
| Z-0290-2025 | Class I | Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B | Oct 7, 2024 |