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Philips Respironics, Inc.

Philips Respironics, Inc. Recalls

All product recalls associated with Philips Respironics, Inc..

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Recall Summary

Total Recalls

139

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 139 recalls

Philips Respironics, Inc.: BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (...

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.

FDAMar 26, 2024Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo O2, all software versions except 1.05.06.00. ...

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

FDAMar 19, 2024Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy EV300, all software versions except 1.05.06.00. V...

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

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FDA

Mar 19, 2024

Nationwide

• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo Universal Ventilator, all software versions e...

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

FDAMar 19, 2024Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: LifeVentEVO2, all software versions except 1.05.06.00. Ve...

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

FDAMar 19, 2024Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Garbin EVO, all software versions except 1.05.06.00. Vent...

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

FDAMar 19, 2024Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo, all software versions except 1.05.06.00. Ven...

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

FDAMar 19, 2024Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Aeris EVO, all software versions except 1.05.06.00. Venti...

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

FDAMar 19, 2024Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15...

The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.

FDANov 27, 2023Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Philips Respironics V60/V60 Plus Ventilator, PCBA Part ...

Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.

FDAAug 25, 2023CA, OH, OR +1 more• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregi...

There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".

FDAMay 25, 2023Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2...

Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.

FDAMay 1, 2023Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo Universal Ventilator, Model Number DS2000X11B

The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.

FDAMay 1, 2023Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15...

FDAMay 1, 2023Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11...

FDAMay 1, 2023Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy EV300 Portable Electric Ventilator, Model Numbers...

The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.

FDAMar 1, 2023Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventila...

FDAMar 1, 2023Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo Universal Portable Electric Ventilator, Model...

FDAMar 1, 2023Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Philips DreamStation Auto BiPAP and CPAP, Model Numbers U...

A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription settings to the device or the device may have incorrect prescription settings for the patient.

FDAFeb 10, 2023Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1...

The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.

FDADec 7, 2022Nationwide• Philips Respironics, Inc.