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Philips Respironics Recalls
94 recalls on record · March 16, 2016 to April 8, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 8, 2026Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Hazard: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
April 8, 2026Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Hazard: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
April 8, 2026Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Hazard: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
April 8, 2026Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Hazard: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
April 1, 2026Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Hazard: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
April 1, 2026Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Hazard: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
April 1, 2026Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Hazard: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
April 1, 2026Medical DevicesFDA
Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Hazard: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
November 19, 2025Medical DevicesFDA
Philips Respironics, Inc. recalls SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for th
Hazard: Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
August 20, 2025Medical DevicesFDA
Philips Respironics, Inc. recalls DreamStation Auto. Non-Continuous Ventilator.
Hazard: Devices may possess a programming error resulting in an incorrect device configuration.
August 20, 2025Medical DevicesFDA
Philips Respironics, Inc. recalls DreamStation Auto BiPAP. Non-Continuous Ventilator.
Hazard: Devices may possess a programming error resulting in an incorrect device configuration.
August 20, 2025Medical DevicesFDA
Philips Respironics, Inc. recalls DreamStation Auto CPAP. Non-Continuous Ventilator.
Hazard: Devices may possess a programming error resulting in an incorrect device configuration.
July 9, 2025Medical DevicesFDA
Philips Respironics, Inc. recalls BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric pa
Hazard: This device does not indicate for use in patients with respiratory failure.
July 9, 2025Medical DevicesFDA
Philips Respironics, Inc. recalls BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more
Hazard: This device does not indicate for use in patients with respiratory failure.
July 9, 2025Medical DevicesFDA
Philips Respironics, Inc. recalls BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighin
Hazard: This device does not indicate for use in patients with respiratory failure.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult
Hazard: 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.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult pa
Hazard: 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.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult pat
Hazard: 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.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200
Hazard: 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.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediat
Hazard: 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.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110
Hazard: 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.
November 20, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100
Hazard: 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.
September 11, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2
Hazard: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
September 11, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Hazard: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
September 11, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy E
Hazard: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
May 29, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 11111
Hazard: Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.
May 29, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11
Hazard: Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
May 29, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 11111
Hazard: Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
May 29, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls BiPAP V30 Auto Ventilator, Part Number 1111178
Hazard: Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.