Philips Respironics, Inc.
15 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Philips Respironics, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-08FDA-DeviceClass IPhilips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
- 2026-04-08FDA-DeviceClass IPhilips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
- 2026-04-08FDA-DeviceClass IPhilips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
- 2026-04-08FDA-DeviceClass IPhilips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
- 2026-04-01FDA-DeviceClass IPhilips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
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.
- 2026-04-01FDA-DeviceClass IPhilips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
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.
- 2026-04-01FDA-DeviceClass IPhilips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
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.
- 2026-04-01FDA-DeviceClass IPhilips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
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.
- 2025-11-19FDA-DeviceClass IISimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
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.
- 2025-08-20FDA-DeviceClass IDreamStation Auto. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
- 2025-08-20FDA-DeviceClass IDreamStation Auto BiPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
- 2025-08-20FDA-DeviceClass IDreamStation Auto CPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
- 2025-07-09FDA-DeviceClass IBiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
This device does not indicate for use in patients with respiratory failure.
- 2025-07-09FDA-DeviceClass IBiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
This device does not indicate for use in patients with respiratory failure.
- 2025-07-09FDA-DeviceClass IBiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
This device does not indicate for use in patients with respiratory failure.
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