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Philips Respironics, Inc. Recalls

61 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Philips Respironics, Inc..

61Total Recalls
53Critical
14.1MUnits Affected
Mar 2, 2026Most Recent
All Recalls

Every Philips Respironics, Inc. Recall

Sorted by most recent. Click any recall for full details.

61 recalls
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Respiratory Devices·113,717 affected·Mar 2, 2026
High RiskFDA
Philips Respironics, Inc.
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: ...
Respiratory Devices·56 affected·Oct 7, 2025
CriticalFDA
Philips Respironics, Inc.
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Respiratory Devices·8 affected·Jun 30, 2025
CriticalFDA
Philips Respironics, Inc.
DreamStation Auto. Non-Continuous Ventilator.
Respiratory Devices·28 affected·Jun 30, 2025
CriticalFDA
Philips Respironics, Inc.
DreamStation Auto CPAP. Non-Continuous Ventilator.
Respiratory Devices·57 affected·Jun 30, 2025
CriticalFDA
Philips Respironics, Inc.
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A...
Respiratory Devices·6 affected·May 9, 2025
CriticalFDA
Philips Respironics, Inc.
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Respiratory Devices·5,958 affected·May 9, 2025
CriticalFDA
Philips Respironics, Inc.
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. Bi...
Respiratory Devices·3 affected·May 9, 2025
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult...
Respiratory Devices·9,999 affected·Oct 7, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B,...
Respiratory Devices·34,146 affected·Oct 7, 2024
CriticalFDA
Philips Respironics, Inc.
Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at...
Respiratory Devices·804 affected·Oct 7, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy E...
Medical Devices·90,910 affected·Jul 16, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Respiratory Devices·90,910 affected·Jul 16, 2024
CriticalFDA
Philips Respironics, Inc.
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R111...
Respiratory Devices·9,388 affected·Apr 1, 2024
CriticalFDA
Philips Respironics, Inc.
BiPAP V30 Auto Ventilator, Part Number 1111178
Respiratory Devices·5,958 affected·Mar 26, 2024
CriticalFDA
Philips Respironics, Inc.
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111...
Respiratory Devices·6 affected·Mar 26, 2024
CriticalFDA
Philips Respironics, Inc.
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1...
Respiratory Devices·3 affected·Mar 26, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Respiratory Devices·9,999 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Respiratory Devices·1,002 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Respiratory Devices·775 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Respiratory Devices·789 affected·Mar 19, 2024
CriticalFDA
Philips Respironics, Inc.
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Phil...
Respiratory Devices·15 affected·Aug 25, 2023
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB220...
Medical Devices·18,855 affected·May 1, 2023
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B,...
Medical Devices·57,395 affected·May 1, 2023
CriticalFDA
Philips Respironics, Inc.
Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used ...
Respiratory Devices·1,233 affected·Feb 10, 2023
CriticalFDA
Philips Respironics, Inc.
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260,...
Respiratory Devices·20,807 affected·Dec 7, 2022
CriticalFDA
Philips Respironics, Inc.
Wisp and Wisp Youth Nasal Mask
Medical Devices·6,237,558 affected·Sep 6, 2022
CriticalFDA
Philips Respironics, Inc.
DreamWisp Nasal Mask with Over the Nose Cushion
Medical Devices·930,813 affected·Sep 6, 2022
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Amara View Minimal Contact Full-Face Mask
Medical Devices·5,661,639 affected·Sep 6, 2022
CriticalFDA
Philips Respironics, Inc.
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and resp...
Respiratory Devices·146 affected·Aug 26, 2022
CriticalFDA
Philips Respironics, Inc.
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and...
Respiratory Devices·295 affected·Aug 26, 2022
CriticalFDA
Philips Respironics, Inc.
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea...
Respiratory Devices·34 affected·Aug 26, 2022
CriticalFDA
Philips Respironics, Inc.
Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructiv...
Respiratory Devices·8 affected·Aug 26, 2022
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent p...
Respiratory Devices·473 affected·Dec 22, 2021
CriticalFDA
Philips Respironics, Inc.
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or int...
Respiratory Devices·205 affected·Dec 22, 2021
High RiskFDA
Philips Respironics, Inc.
Trilogy Evo Universal, Product number DS2000X11B
Medical Devices·10,000 affected·Jul 26, 2021
High RiskFDA
Philips Respironics, Inc.
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15...
Medical Devices·101 affected·Jul 26, 2021
CriticalFDA
Philips Respironics, Inc.
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
Respiratory Devices·255,810 affected·Jun 14, 2021
CriticalFDA
Philips Respironics, Inc.
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Respiratory Devices·72,665 affected·Jun 14, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
Respiratory Devices·1 affected·Apr 6, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
Respiratory Devices·2 affected·Apr 6, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
Respiratory Devices·4 affected·Apr 6, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
Respiratory Devices·4 affected·Apr 6, 2021
High RiskFDA
Philips Respironics, Inc.
BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
Respiratory Devices·10 affected·Apr 6, 2021