The Recall Desk

Manufacturer

Philips Respironics, Inc.

74 recalls in our database name Philips Respironics, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–74 of 74

  • SevereFDA (Devices)·Z-1781-2022·2022-10-12

    CPAP Mask Recall Due to Missing Safety Warnings for Magnetic Components

    Philips Respironics is recalling DreamWear Full Face Masks because they lack warnings about magnetic components that could interfere with implantable devices and risk eye injury from metallic splinters.

    Product
    Philips Respironics DreamWear Full Face Mask
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1783-2022·2022-10-12

    Wisp and Wisp Youth nasal masks recalled for missing implanted device warnings

    Philips Respironics is recalling Wisp and Wisp Youth nasal masks because they lack warnings about magnetic components that could interfere with implanted medical devices or cause eye injuries from metallic splinters.

    Product
    Wisp and Wisp Youth Nasal Mask
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1782-2022·2022-10-12

    DreamWisp CPAP mask recalled for missing implant safety warnings

    Philips Respironics is recalling 930,813 DreamWisp Nasal Masks worldwide due to missing warnings about magnetic components that could interfere with implantable medical devices or cause metallic splinters.

    Product
    DreamWisp Nasal Mask with Over the Nose Cushion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1780-2022·2022-10-12

    CPAP Full-Face Mask Recalled for Missing Implantable Device Warnings

    Philips Respironics Amara View Full-Face Mask lacks critical safety warnings about magnetic components for patients with implantable medical devices. The Class I recall affects 5.6 million units worldwide.

    Product
    Philips Respironics Amara View Minimal Contact Full-Face Mask
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1784-2022·2022-10-12

    Philips Therapy Mask 3100 NC/SP CPAP masks lack required magnetic warnings

    Philips Respironics is recalling Therapy Mask 3100 NC/SP CPAP masks because they lack warnings about magnetic components that could interfere with implantable medical devices. Approximately 42,954 units have been distributed worldwide.

    Product
    Therapy Mask 3100 NC/SP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1658-2022·2022-09-14

    Philips OmniLab Advanced+ Ventilation Devices Recalled for Plastic Off-Gassing

    Philips Respironics is recalling certain Philips OmniLab Advanced+ noninvasive ventilation devices due to motor assemblies with nonconforming plastic that can off-gas volatile organic compounds (VOCs). This is an FDA Class I recall.

    Product
    Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1654-2022·2022-09-14

    Philips BiPAP A30 respiratory device motor assemblies recalled for VOC off-gassing

    Philips Respironics recalls Philips BiPAP A30 respiratory devices due to motor assemblies with nonconforming plastic that off-gases volatile organic compounds (VOCs). Patients should contact the manufacturer immediately.

    Product
    Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1659-2022·2022-09-14

    Philips OmniLab ventilator recalled for motor assembly plastic off-gassing defect

    Philips Respironics is recalling OmniLab Advanced + ventilators due to motor assemblies manufactured with nonconforming plastic that releases volatile organic compounds (VOCs). The 8 affected units were distributed across the US and internationally.

    Product
    Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1656-2022·2022-09-14

    Philips BiPAP V30 Auto Respirators Recalled for VOC Off-Gassing Risk

    Philips Respironics recalls 295 BiPAP V30 Auto respiratory devices due to motor assemblies with nonconforming plastic. These assemblies off-gas volatile organic compounds (VOCs) during device operation.

    Product
    Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1657-2022·2022-09-14

    Philips OmniLab Advanced+ sleep apnea devices recalled for off-gassing

    Philips Respironics is recalling 85 units of the OmniLab Advanced+ ventilation device due to motor assemblies containing nonconforming plastic that off-gasses volatile organic compounds.

    Product
    Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1655-2022·2022-09-14

    Philips BiPAP A40 Respiratory Devices Recalled for Motor Assembly Off-Gassing

    Philips is recalling BiPAP A40 respiratory support devices because motor assemblies were manufactured with nonconforming plastic that off-gases volatile organic compounds (VOCs). Approximately 1,414 units have been distributed domestically and internationally.

    Product
    Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-0785-2022·2022-03-30

    Philips Respironics respiratory ventilators recalled for foam degradation

    Philips Respironics recalls 229,353 respiratory ventilators because polyester-polyurethane foam may degrade and release particles. Foam degradation could compromise ventilator function.

    Product
    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0494-2022·2022-02-02

    Trilogy Evo Ventilator Repair Kit Recalled for Degrading Foam Material

    Philips Respironics recalled 205 Trilogy Evo ventilator repair kits containing non-conforming foam material that may degrade into particles potentially inhaled or ingested by users. The affected kits were distributed in the US and internationally.

    Product
    Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric t
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0493-2022·2022-02-02

    Trilogy Evo Ventilator Recalled for Foam Degradation Risk

    Philips Respironics recalls 473 Trilogy Evo ventilators due to non-conforming foam that may degrade and release particles. Affected patients risk inhaling or ingesting foam particles and chemicals during device use.

    Product
    Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adul
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2288-2021·2021-08-25

    Trilogy Evo O2 Ventilator Software Issues Affecting Pressure Delivery

    Philips Respironics is recalling Trilogy Evo O2 ventilators with software issues that can increase pressure delivery. One issue affects infant/pediatric settings; another causes pressure drift during continuous use.

    Product
    Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2021·2021-08-25

    Trilogy Evo Respiratory Device Recalled for Software Pressure Issues

    Philips Respironics has recalled Trilogy Evo Universal respiratory devices (model DS2000X11B) for software defects that increase pressure, particularly in pediatric and infant applications.

    Product
    Trilogy Evo Universal, Product number DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2021·2021-08-25

    Trilogy Evo Ventilator Software Defect May Cause Pressure Increase

    Philips Respironics recalls Trilogy Evo ventilators due to software issues that may increase pressure delivery to patients. The defect affects multiple product variants worldwide.

    Product
    Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2021·2021-08-25

    Trilogy EV300 Ventilator Recalled for Software-Related Pressure Calibration Issues

    Philips Respironics is recalling the Trilogy EV300 ventilator due to software issues causing pressure calibration errors affecting infant and pediatric patients. The defects impact 18,936 units distributed in the United States.

    Product
    Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1956-2021·2021-07-21

    Philips Respironics Continuous Ventilators Recalled for Foam Degradation Risk

    Philips Respironics is recalling approximately 255,810 continuous ventilators because polyurethane foam may degrade into particles that could be inhaled or ingested, or release chemicals.

    Product
    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1974-2021·2021-07-21

    Philips Respironics ventilators recalled for degrading foam and chemical hazards

    Philips Respironics ventilators are recalled because foam components may degrade and release particles and chemicals that patients could inhale.

    Product
    SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1957-2021·2021-07-21

    Philips Respironics BiPAP ventilators recalled for foam degradation and off-gassing

    Philips Respironics BiPAP ventilators' polyurethane foam may degrade into particles that could be inhaled or ingested, or off-gas certain chemicals. About 8,047 devices worldwide are affected.

    Product
    A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1958-2021·2021-07-21

    Philips BiPAP A-Series Ventilators Recalled for Foam Degradation Risk

    Philips Respironics recalled 72,665 BiPAP A-Series ventilators worldwide. The foam in these devices may degrade into particles that could be inhaled or ingested, and may release chemicals.

    Product
    A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1973-2021·2021-07-21

    Philips Respironics ventilators recalled due to foam degradation and chemical release

    Philips Respironics ventilators and respiratory support devices are being recalled because polyurethane foam components may degrade into particles that can be inhaled or ingested, and the foam may release harmful chemicals.

    Product
    DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individu
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1972-2021·2021-07-21

    Philips Respironics E30 ventilator foam degradation poses inhalation hazard

    Philips Respironics E30 ventilators may have polyurethane foam that degrades into particles. These particles can enter the air pathway and be inhaled or ingested by patients, or the foam may off-gas chemicals.

    Product
    Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for indiv
    Category
    Medical Device
    Distribution
    0 states