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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

7

Class I (Serious)

1

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 41–60 of 139 recalls

Philips Respironics, Inc.: Philips Garbin Ventilator, Model Number 1058180B

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.

Philips Respironics, Inc.: Philips Trilogy 100 Ventilator, Model Numbers 1054260, 10...

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.

Philips Respironics, Inc.: Wisp and Wisp Youth Nasal Mask

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No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

FDASep 6, 2022Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Therapy Mask 3100 NC/SP

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

FDASep 6, 2022Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Philips Respironics Amara View Minimal Contact Full-Face ...

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

FDASep 6, 2022Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Philips Respironics DreamWear Full Face Mask

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

FDASep 6, 2022Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: DreamWisp Nasal Mask with Over the Nose Cushion

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

FDASep 6, 2022Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Philips OmniLab Advanced + with Heated Tube Humidifier, R...

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

Philips Respironics, Inc.: Philips BiPAP A30, Rx Only. To provide noninvasive venti...

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

Philips Respironics, Inc.: Philips OmniLab Advanced+, Rx Only. To provide noninvasi...

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

Philips Respironics, Inc.: Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ...

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

Philips Respironics, Inc.: Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To p...

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

Philips Respironics, Inc.: Philips BiPAP A40, Rx Only. To provide noninvasive venti...

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

FDAAug 26, 2022AL, AK, AZ +39 more• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110...

Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.

FDADec 22, 2021AR, CO, FL +14 more• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, ...

Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.

FDADec 22, 2021AR, CO, FL +14 more• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, E...

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

FDAJul 26, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX...

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

FDAJul 26, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE21...

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

FDAJul 26, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: Trilogy Evo Universal, Product number DS2000X11B

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

FDAJul 26, 2021Nationwide• Philips Respironics, Inc.

Philips Respironics, Inc.: SystemOne (Q-Series), DreamStation, DreamStation Go, Dor...

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

FDAJun 14, 2021Nationwide• Philips Respironics, Inc.