Philips Respironics, Inc.
58 recalls on record · Latest: Nov 19, 2025
FDA Devices Moderate Nov 19, 2025
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mi…
FDA Devices Critical Aug 20, 2025
DreamStation Auto BiPAP. Non-Continuous Ventilator.
FDA Devices Critical Aug 20, 2025
DreamStation Auto. Non-Continuous Ventilator.
FDA Devices Critical Aug 20, 2025
DreamStation Auto CPAP. Non-Continuous Ventilator.
FDA Devices Critical Jul 9, 2025
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sol…
FDA Devices Critical Jul 9, 2025
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
FDA Devices Critical Jul 9, 2025
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A…
FDA Devices Critical Nov 20, 2024
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients we…
FDA Devices Critical Nov 20, 2024
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B,…
FDA Devices Critical Nov 20, 2024
Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 k…
FDA Devices Critical Sep 11, 2024
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil …
FDA Devices Critical Sep 11, 2024
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
FDA Devices Critical May 29, 2024
BiPAP V30 Auto Ventilator, Part Number 1111178
FDA Devices Critical May 29, 2024
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156…
FDA Devices Critical May 29, 2024
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R111112…
FDA Devices Critical May 29, 2024
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111…
FDA Devices Critical Apr 24, 2024
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
FDA Devices Critical Apr 24, 2024
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
FDA Devices Critical Apr 24, 2024
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
FDA Devices Critical Apr 24, 2024
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
FDA Devices Critical Oct 4, 2023
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
FDA Devices Critical Jun 14, 2023
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU220…
FDA Devices Critical Jun 14, 2023
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B,…
FDA Devices Critical Jun 14, 2023
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
FDA Devices Critical Apr 12, 2023
Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver p…
FDA Devices Critical Jan 18, 2023
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260,…
FDA Devices Critical Oct 12, 2022
Wisp and Wisp Youth Nasal Mask
FDA Devices Critical Oct 12, 2022
DreamWisp Nasal Mask with Over the Nose Cushion
FDA Devices Critical Oct 12, 2022
Philips Respironics Amara View Minimal Contact Full-Face Mask
FDA Devices Critical Sep 14, 2022
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insu…
FDA Devices Critical Sep 14, 2022
Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory…
FDA Devices Critical Sep 14, 2022
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (O…
FDA Devices Critical Sep 14, 2022
Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apne…
FDA Devices Critical Feb 2, 2022
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pres…
FDA Devices Critical Feb 2, 2022
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent po…
FDA Devices Moderate Aug 25, 2021
Trilogy Evo Universal, Product number DS2000X11B
FDA Devices Moderate Aug 25, 2021
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19…
FDA Devices Moderate Aug 25, 2021
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
FDA Devices Critical Jul 21, 2021
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
FDA Devices Critical Jul 21, 2021
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
FDA Devices Moderate Jun 2, 2021
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
FDA Devices Moderate Jun 2, 2021
BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
FDA Devices Moderate Jun 2, 2021
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
FDA Devices Moderate Jun 2, 2021
BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
FDA Devices Moderate Jun 2, 2021
BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
FDA Devices Critical Feb 26, 2020
Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. …
FDA Devices Critical Feb 26, 2020
Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. T…
FDA Devices Critical Feb 26, 2020
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The v…
FDA Devices Critical Feb 26, 2020
Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. T…
FDA Devices Critical Feb 26, 2020