Philips Respironics, Inc.

Complete recall history across all FDA and CPSC categories — 89 total recalls

Philips Respironics, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (89)

FDA medical device enforcement actions by Philips Respironics, Inc.. Showing most recent 50.

Date Product Reason Class
Mar 2, 2026 Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... In some situations, the Obstruction Alarm does not trigger within the timefra... Class I
Mar 2, 2026 Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... In some situations, the Obstruction Alarm does not trigger within the timefra... Class I
Mar 2, 2026 Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... In some situations, the Obstruction Alarm does not trigger within the timefra... Class I
Mar 2, 2026 Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... In some situations, the Obstruction Alarm does not trigger within the timefra... Class I
Mar 2, 2026 Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may resu... Class I
Mar 2, 2026 Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may resu... Class I
Mar 2, 2026 Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may resu... Class I
Mar 2, 2026 Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may resu... Class I
Oct 7, 2025 SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected ... Certain serial numbers of the SimplyGo Mini standard battery kit contain a de... Class II
Jun 30, 2025 DreamStation Auto CPAP. Non-Continuous Ventilator. Devices may possess a programming error resulting in an incorrect device conf... Class I
Jun 30, 2025 DreamStation Auto. Non-Continuous Ventilator. Devices may possess a programming error resulting in an incorrect device conf... Class I
Jun 30, 2025 DreamStation Auto BiPAP. Non-Continuous Ventilator. Devices may possess a programming error resulting in an incorrect device conf... Class I
May 9, 2025 BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in... This device does not indicate for use in patients with respiratory failure. Class I
May 9, 2025 BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the... This device does not indicate for use in patients with respiratory failure. Class I
May 9, 2025 BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory suppo... This device does not indicate for use in patients with respiratory failure. Class I
Oct 7, 2024 Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B,... Potential for in-line nebulizer configuration in certain locations to result ... Class I
Oct 7, 2024 Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B,... Potential for in-line nebulizer configuration in certain locations to result ... Class I
Oct 7, 2024 LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invas... Potential for in-line nebulizer configuration in certain locations to result ... Class I
Oct 7, 2024 Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasiv... Potential for in-line nebulizer configuration in certain locations to result ... Class I
Oct 7, 2024 Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive... Potential for in-line nebulizer configuration in certain locations to result ... Class I
Oct 7, 2024 Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B,... Potential for in-line nebulizer configuration in certain locations to result ... Class I
Oct 7, 2024 Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for inva... Potential for in-line nebulizer configuration in certain locations to result ... Class I
Jul 16, 2024 Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Ev... Firm has released a mandatory software update Version 1.05.10.00 and a User M... Class I
Jul 16, 2024 Trilogy Evo Universal Ventilator, Model No. DS2000X11B Firm has released a mandatory software update Version 1.05.10.00 and a User M... Class I
Jul 16, 2024 Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Aust... Firm has released a mandatory software update Version 1.05.10.00 and a User M... Class I
Apr 1, 2024 OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 11... Device may experience an interruption or loss of therapy in case of a Ventila... Class I
Mar 26, 2024 BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbe... Potential for devices to experience interruption/loss of therapy during a Ven... Class I
Mar 26, 2024 BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and ... Potential for devices to experience interruption/loss of therapy during a Ven... Class I
Mar 26, 2024 BiPAP V30 Auto Ventilator, Part Number 1111178 Potential for devices to experience interruption/loss of therapy during a Ven... Class I
Mar 19, 2024 Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatri... Potential for sudden loss of ventilation due to Battery Depleted or Loss of P... Class I
Mar 19, 2024 Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric... Potential for sudden loss of ventilation due to Battery Depleted or Loss of P... Class I
Mar 19, 2024 Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediat... Potential for sudden loss of ventilation due to Battery Depleted or Loss of P... Class I
Mar 19, 2024 Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pedia... Potential for sudden loss of ventilation due to Battery Depleted or Loss of P... Class I
Mar 19, 2024 Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric ... Potential for sudden loss of ventilation due to Battery Depleted or Loss of P... Class I
Mar 19, 2024 LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatr... Potential for sudden loss of ventilation due to Battery Depleted or Loss of P... Class I
Mar 19, 2024 Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ve... Potential for sudden loss of ventilation due to Battery Depleted or Loss of P... Class I
Nov 27, 2023 Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA21... The following was missing from the Contraindications Statement: The AVAPS-AE ... Class II
Aug 25, 2023 Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 4535615444... Power Management PCBAs may malfunction, causing a power failure leading to ve... Class I
May 25, 2023 Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853)... There are errors present in the Korean Instructions For Use where the word "i... Class II
May 1, 2023 Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN210... Environmental debris may accumulate on the internal machine flow sensor causi... Class I
May 1, 2023 Trilogy Evo Universal Ventilator, Model Number DS2000X11B The Trilogy Evo Universal ventilator provides continuous or intermittent posi... Class I
May 1, 2023 Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B,... Environmental debris may accumulate on the internal machine flow sensor causi... Class I
May 1, 2023 Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA220... Environmental debris may accumulate on the internal machine flow sensor causi... Class I
Mar 1, 2023 Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers D... The accuracy of delivered oxygen may deviate below the required tolerance of ... Class I
Mar 1, 2023 Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B The accuracy of delivered oxygen may deviate below the required tolerance of ... Class I
Mar 1, 2023 Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X... The accuracy of delivered oxygen may deviate below the required tolerance of ... Class I
Feb 10, 2023 Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S... A limited number of remediated Philips DreamStation units may experience comm... Class I
Dec 7, 2022 Philips Garbin Ventilator, Model Number 1058180B The replacement silicone sound abatement foam installed into some Trilogy 100... Class I
Dec 7, 2022 Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1... The replacement silicone sound abatement foam installed into some Trilogy 100... Class I
Dec 7, 2022 Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U10... The replacement silicone sound abatement foam installed into some Trilogy 100... Class I

View all 89 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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