The Recall Desk

Manufacturer

Philips Respironics, Inc.

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

What the numbers show

Total
93
Critical
7
Severe
75
Most recent
2026-04-08

Of the 93 recalls from Philips Respironics, Inc. we have scored against our rubric, 7 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 75 (81%) are Severe.

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 93

  • SevereFDA (Devices)·Z-1648-2026·2026-04-08

    Trilogy EV300 obstruction alarm may take up to four breaths

    Philips Respironics is recalling the Trilogy EV300 ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.

    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

    Trilogy Evo Universal obstruction alarm may take up to four breaths

    Philips Respironics is recalling the Trilogy Evo Universal ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.

    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

    Trilogy Evo O2 obstruction alarm may take up to four breaths

    Philips Respironics is recalling the Trilogy Evo O2 ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.

    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-1646-2026·2026-04-08

    Trilogy Evo obstruction alarm may take up to four breaths

    Philips Respironics is recalling the Trilogy Evo ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.

    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-1616-2026·2026-04-01

    Trilogy EV300 ventilator recalled as Class I over tidal volume

    Philips Respironics is recalling the Trilogy EV300 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.

    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

    Trilogy Evo O2 ventilator recalled as Class I over tidal volume

    Philips Respironics is recalling the Trilogy Evo O2 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.

    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-1614-2026·2026-04-01

    Trilogy Evo ventilator recalled as Class I over tidal volume

    Philips Respironics is recalling the Trilogy Evo ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.

    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-1617-2026·2026-04-01

    Trilogy Evo Universal ventilator recalled as Class I over tidal volume

    Philips Respironics is recalling the Trilogy Evo Universal ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.

    Product
    Philips Respironics Trilogy Evo Universal, 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

    Oxygen concentrator batteries recalled over a chip that can stop oxygen

    Philips Respironics is recalling 56 SimplyGo Mini standard battery kits because a defective chip can make the battery fail, shutting down the concentrator and stopping oxygen delivery.

    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-2227-2025·2025-08-20

    DreamStation Auto CPAP units may hold an incorrect device configuration

    DreamStation Auto CPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 57 units are affected.

    Product
    DreamStation Auto CPAP. Non-Continuous Ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2228-2025·2025-08-20

    DreamStation Auto BiPAP units may hold an incorrect device configuration

    DreamStation Auto BiPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 8 units are affected.

    Product
    DreamStation Auto BiPAP. Non-Continuous Ventilator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2037-2025·2025-07-09

    BiPAP A40 ventilators are not indicated for respiratory failure patients

    The BiPAP A40 Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 6 units in the US and 67,534 outside it are affected.

    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-2035-2025·2025-07-09

    BiPAP V30 Auto ventilators are not indicated for respiratory failure

    The Philips Respironics BiPAP V30 Auto Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 5,958 units affected.

    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 and BiPAP Hybrid A30 Ventilators Recalled by Philips

    Philips Respironics is recalling BiPAP A30 and BiPAP Hybrid A30 ventilators. The devices do not have an indication 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
  • 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-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-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-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
  • 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
  • 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-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
  • 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