Recall Register

Philips Respironics, Inc.: FDA recalls

FDA enforcement reports name Philips Respironics, Inc. as the recalling firm in 26 events. The events have 93 product records. The recalls started from 2018 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

26 events, newest first.

FDA enforcement events of Philips Respironics, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
2 Mar 2026Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.DeviceClass I4Ongoing
2 Mar 2026Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.DeviceClass I4Ongoing
7 Oct 2025SimplyGo 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: 1113600DeviceClass II1Ongoing
30 Jun 2025DreamStation Auto CPAP. Non-Continuous Ventilator.DeviceClass I3Ongoing
9 May 2025BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.DeviceClass I3Ongoing
7 Oct 2024Trilogy 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 pediatric through adult patients weighing at…DeviceClass I7Ongoing
16 Jul 2024Trilogy 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 Trilogy Evo, O2, USA EV300; EE2200X15B…DeviceClass I3Ongoing
1 Apr 2024OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124DeviceClass I1Ongoing
26 Mar 2024BiPAP V30 Auto Ventilator, Part Number 1111178DeviceClass I3Ongoing
19 Mar 2024Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)DeviceClass I7Ongoing
27 Nov 2023Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA2110X15B IN2100X15B IN2100X19 IN2110X15B IT2100X21B…DeviceClass II1Ongoing
25 Aug 2023Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)DeviceClass I1Ongoing
25 May 2023Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for UseDeviceClass II1Ongoing
1 May 2023Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24BDeviceClass I4Ongoing
1 Mar 2023Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B,…DeviceClass I3Ongoing
10 Feb 2023Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.DeviceClass I1Ongoing
7 Dec 2022Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096, R1054655TP, R1054655B, 1054655,…DeviceClass I3Ongoing
6 Sep 2022Philips Respironics Amara View Minimal Contact Full-Face MaskDeviceClass I5Ongoing
26 Aug 2022Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.DeviceClass I6Ongoing
22 Dec 2021Trilogy 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 adult patients weighing at least 2.5 kg.DeviceClass I2Ongoing
26 Jul 2021Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11BDeviceClass II4Ongoing
14 Jun 2021Philips 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 individuals with Respiratory Insufficiency. It…DeviceClass I3Ongoing
14 Jun 2021Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.DeviceClass I3Ongoing
6 Apr 2021BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178DeviceClass II6Terminated
19 Nov 2019Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo 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.DeviceClass I13Terminated
12 Jun 2018Trilogy 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 intended to be used as a transport…DeviceClass I1Ongoing

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Philips Respironics, Inc.: events for each product type
TypeEvents
Device26
Philips Respironics, Inc.: events in each class
ClassEvents
Class I21
Class II5
Share of the events of the firm in Class I
81%
Share of all events on the register in Class I
18%
Events with the status Ongoing
24

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Philips Respironics, Inc., by the year that the recall started. The largest year is 2023, with 6 events.

Official channels

Cite this page

Recall Register. Philips Respironics, Inc.: FDA recalls. https://recallregister.com/firm/philips-respironics-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
PA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Philips Respironics, Inc. have?
Class I: 21 events. Class II: 5 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Philips Respironics, Inc.?
FDA event 98540, which the firm started on 2 Mar 2026. The first product in the record is: Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
How many FDA recalls of Philips Respironics, Inc. have the status Ongoing?
24 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.