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.

1–25 of 74

  • SevereFDA (Devices)·Z-1646-2026·2026-04-08

    Home Ventilator Obstruction Alarm May Fail to Trigger Promptly

    The Philips Respironics Trilogy Evo home ventilator's obstruction alarm may not trigger within required timeframes, potentially delaying detection of airway blockages. Approximately 113,717 units are affected worldwide.

    Product
    Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1648-2026·2026-04-08

    Philips Respironics Trilogy EV300 Ventilator Recall: Obstruction Alarm Delay

    Philips Respironics Trilogy EV300 ventilators are recalled because the obstruction alarm may not trigger within required timeframes, potentially delaying detection of airway blockages. Over 113,000 units are affected worldwide.

    Product
    Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1649-2026·2026-04-08

    Philips Respironics Trilogy Evo Universal Ventilator Obstruction Alarm Delay Recalled

    Philips Respironics Trilogy Evo Universal ventilator software version 1.05.15.00 recalled because the obstruction alarm may fail to trigger within required timeframes, potentially delaying critical responses to airway obstruction.

    Product
    Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1647-2026·2026-04-08

    Home Ventilator Alarm May Fail to Detect Airway Obstruction Promptly

    The Philips Respironics Trilogy Evo O2 ventilator's obstruction alarm may not trigger promptly, taking up to four breaths to respond. This delay could prevent timely detection of a blocked airway in patients depending on the device for breathing support.

    Product
    Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1616-2026·2026-04-01

    Philips Respironics ventilator may deliver incorrect air volume with nebulizers

    Philips Respironics Trilogy EV300 ventilators may deliver an incorrect amount of air when used with non-pneumatic nebulizers, potentially affecting respiratory support in dependent patients.

    Product
    Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1615-2026·2026-04-01

    Philips Trilogy Evo O2 Ventilator Breathing Support Discrepancy with Non-Pneumatic Nebulizers

    Philips Respironics Trilogy Evo O2 ventilators may not deliver the correct breathing support when used with non-pneumatic nebulizers. Verify nebulizer compatibility and contact Philips for guidance.

    Product
    Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1617-2026·2026-04-01

    Philips Respironics Trilogy Evo Ventilator Tidal Volume Discrepancy Recall

    Philips Respironics Trilogy Evo Universal ventilators may have tidal volume discrepancies when used with non-pneumatic nebulizers. Approximately 113,717 units distributed worldwide are affected by this Class I recall.

    Product
    Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1614-2026·2026-04-01

    Philips Respironics Trilogy Evo Ventilator May Deliver Incorrect Tidal Volume

    Philips Respironics Trilogy Evo ventilators may deliver incorrect tidal volume to patients when used with non-pneumatic nebulizers. This discrepancy between set and delivered volume poses a risk to home-use patients.

    Product
    Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0481-2026·2025-11-19

    Philips SimplyGo Mini battery kits may shut down and stop oxygen delivery

    Certain SimplyGo Mini battery kits contain a defective chip that may fail to charge or lose power during use, causing the oxygen concentrator to shut down. The defect affects 56 units distributed in six US states and Canada.

    Product
    SimplyGo 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2228-2025·2025-08-20

    DreamStation Auto BiPAP Ventilators Recalled Due to Programming Error

    Philips is recalling 8 DreamStation Auto BiPAP ventilators due to a programming error that may result in incorrect device configuration. Affected units are distributed nationwide and in France.

    Product
    DreamStation Auto BiPAP. Non-Continuous Ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2229-2025·2025-08-20

    DreamStation Auto Non-Continuous Ventilator Recalled for Programming Error

    Philips Respironics is recalling the DreamStation Auto Non-Continuous Ventilator due to a programming error that may result in incorrect device configuration affecting 28 units.

    Product
    DreamStation Auto. Non-Continuous Ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2227-2025·2025-08-20

    Philips DreamStation CPAP Devices Recalled for Programming Configuration Error

    Philips Respironics has recalled 57 DreamStation Auto CPAP devices that may have a programming error causing incorrect device configuration. Affected units were distributed nationwide in the US and in France.

    Product
    DreamStation Auto CPAP. Non-Continuous Ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2035-2025·2025-07-09

    Philips BiPAP V30 Auto Ventilator Recalled for Incorrect Indication Labeling

    Philips Respironics recalled 5,958 BiPAP V30 Auto Ventilators worldwide due to incorrect labeling indicating use for respiratory failure patients. The device is not indicated for respiratory failure.

    Product
    BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2036-2025·2025-07-09

    BiPAP A30 Ventilators Recalled for Improper Respiratory Failure Indication

    Philips Respironics recalls BiPAP A30 and BiPAP Hybrid A30 ventilators due to labeling deficiency. The devices do not indicate for use in patients with respiratory failure.

    Product
    BiPAP 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2037-2025·2025-07-09

    BiPAP A40 Ventilator Recalled for Improper Respiratory Failure Patient Use

    Philips Respironics BiPAP A40 ventilators are being recalled because they are not indicated for use in patients with respiratory failure. The device may not be appropriate for this patient population.

    Product
    BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0294-2025·2024-11-20

    Aeris EVO Ventilator May Develop Flow Sensor Fouling from Aerosols

    Philips Respironics Aeris EVO ventilators may accumulate aerosol deposits on the internal flow sensor, potentially causing inaccurate flow measurements.

    Product
    Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0292-2025·2024-11-20

    Trilogy Evo Universal Ventilator Recalled Due to Sensor Malfunction Risk

    Trilogy Evo Universal Ventilators (Model DS2000X11B) are recalled because in-line nebulizer configuration in certain locations could cause aerosol accumulation on the internal flow sensor, potentially resulting in inaccurate measurements.

    Product
    Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0291-2025·2024-11-20

    Philips Trilogy Evo ventilators recall: flow sensor fouling risk

    Philips Respironics is recalling Trilogy Evo ventilators due to potential aerosol deposits on the internal flow sensor, which could cause inaccurate flow measurements during ventilation.

    Product
    Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0293-2025·2024-11-20

    Trilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation

    Philips Respironics is recalling 34,146 Trilogy EV300 ventilators due to potential aerosol accumulation on the internal flow sensor, which could cause inaccurate ventilation measurements.

    Product
    Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive venti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0290-2025·2024-11-20

    Trilogy Evo O2 Ventilators Recalled for Potential Flow Sensor Malfunction

    Philips Respironics recalled 24,249 Trilogy Evo O2 ventilators because in-line nebulizer configurations may allow aerosol deposits to accumulate on the device's flow sensor, potentially causing inaccurate flow measurements.

    Product
    Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pedi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0295-2025·2024-11-20

    Ventilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure

    Philips Respironics is recalling 1,322 Garbin Evo ventilators (Model LD2110X23B) worldwide due to potential aerosol accumulation that could cause inaccurate flow sensor readings, posing a risk to patient care.

    Product
    Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0296-2025·2024-11-20

    Philips LifeVent EVO2 ventilators recalled for potential sensor accuracy failure

    Philips Respironics is recalling LifeVent EVO2 ventilators due to potential aerosol deposit accumulation on the internal flow sensor that could cause inaccurate measurements during ventilation.

    Product
    LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2943-2024·2024-09-11

    Trilogy Evo Ventilator Software Update for Identified Safety Issues

    Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for the Trilogy Evo Universal Ventilator to address safety issues identified in earlier recalls. Affected units should implement the update.

    Product
    Trilogy Evo Universal Ventilator, Model No. DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2942-2024·2024-09-11

    Trilogy Evo EV300 Ventilator Mandatory Software Update for Safety Issues

    Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo EV300 ventilators to resolve previously identified safety issues. Approximately 90,910 US units and 56,273 international units are affected.

    Product
    Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2944-2024·2024-09-11

    Philips Respironics Trilogy Evo Ventilator Software Update Addresses Safety Issues

    Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo ventilators worldwide to resolve identified safety issues. Users must apply the update and review the updated User Manual.

    Product
    Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, US
    Category
    Medical Device
    Distribution
    Distributed nationwide