FDA recall record · openFDA
Philips Respironics, Inc.
47 FDA recalls on record (2023–2026) — 47 device. 47 still ongoing.
44
Class I (most serious)
3
Class II
0
Class III
47
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power. 7
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the devi 7
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal v 4
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and m 4
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to 3
Recalls
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device. Class I 2026-03-02 Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device. Class I 2026-03-02 Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. Class I 2026-03-02 Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. Class I 2026-03-02 Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device. Class I 2026-03-02 Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device. Class I 2026-03-02 Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. Class I 2026-03-02 Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. Class I 2026-03-02 BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric pa Class I 2025-05-09 DreamStation Auto BiPAP. Non-Continuous Ventilator. Class I 2025-06-30 DreamStation Auto. Non-Continuous Ventilator. Class I 2025-06-30 BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighin Class I 2025-05-09 BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more Class I 2025-05-09 DreamStation Auto CPAP. Non-Continuous Ventilator. Class I 2025-06-30 Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. Class I 2024-03-19 BiPAP V30 Auto Ventilator, Part Number 1111178 Class I 2024-03-26 Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediat Class I 2024-10-07 Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2 Class I 2024-07-16 BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111 Class I 2024-03-26 LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) Class I 2024-03-19 Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) Class I 2024-03-19 Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200 Class I 2024-10-07 OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 11111 Class I 2024-04-01 Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. Class I 2024-03-19 BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11 Class I 2024-03-26 Trilogy Evo Universal Ventilator, Model No. DS2000X11B Class I 2024-07-16 Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult pat Class I 2024-10-07 Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult pa Class I 2024-10-07 LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult Class I 2024-10-07 Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy E Class I 2024-07-16 Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100 Class I 2024-10-07 Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. Class I 2024-03-19 Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110 Class I 2024-10-07 Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US) Class I 2024-03-19 Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. Class I 2024-03-19 Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) Class I 2023-08-25 Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, Class I 2023-05-01 Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110 Class I 2023-05-01 Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, U Class I 2023-02-10 Trilogy Evo Universal Ventilator, Model Number DS2000X11B Class I 2023-05-01 Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR Class I 2023-03-01 Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B Class I 2023-03-01 Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15 Class I 2023-03-01 Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, F Class I 2023-05-01 SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for th Class II 2025-10-07 Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use Class II 2023-05-25 Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B Class II 2023-11-27
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.