Browse Device Recalls
89 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 89 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 89 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| 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 result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| 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 result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| 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 result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| 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 defective chip which c... | Class II | Philips Respironics, Inc. |
| Jun 30, 2025 | DreamStation Auto CPAP. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | Class I | Philips Respironics, Inc. |
| Jun 30, 2025 | DreamStation Auto. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | Class I | Philips Respironics, Inc. |
| Jun 30, 2025 | DreamStation Auto BiPAP. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | Class I | Philips Respironics, Inc. |
| 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 | Philips Respironics, Inc. |
| 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 | Philips Respironics, Inc. |
| 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 | Philips Respironics, Inc. |
| Oct 7, 2024 | Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B,... | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| Oct 7, 2024 | Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B,... | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| 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 in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| 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 in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| 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 in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| Oct 7, 2024 | Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B,... | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| Oct 7, 2024 | Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for inva... | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| 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 Manual addendum for a... | Class I | Philips Respironics, Inc. |
| 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 Manual addendum for a... | Class I | Philips Respironics, Inc. |
| 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 Manual addendum for a... | Class I | Philips Respironics, Inc. |
| 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 Ventilator Inoperative alar... | Class I | Philips Respironics, Inc. |
| 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 Ventilator Inoperative ... | Class I | Philips Respironics, Inc. |
| 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 Ventilator Inoperative ... | Class I | Philips Respironics, Inc. |
| Mar 26, 2024 | BiPAP V30 Auto Ventilator, Part Number 1111178 | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... | Class I | Philips Respironics, Inc. |
| 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 Power alarm while uni... | Class I | Philips Respironics, Inc. |
| 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 Power alarm while uni... | Class I | Philips Respironics, Inc. |
| 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 Power alarm while uni... | Class I | Philips Respironics, Inc. |
| 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 Power alarm while uni... | Class I | Philips Respironics, Inc. |
| 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 Power alarm while uni... | Class I | Philips Respironics, Inc. |
| 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 Power alarm while uni... | Class I | Philips Respironics, Inc. |
| 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 Power alarm while uni... | Class I | Philips Respironics, Inc. |
| 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 therapy mode is cont... | Class II | Philips Respironics, Inc. |
| Aug 25, 2023 | Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 4535615444... | Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of fun... | Class I | Philips Respironics, Inc. |
| 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 "invasive," was incorr... | Class II | Philips Respironics, Inc. |
| May 1, 2023 | Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN210... | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... | Class I | Philips Respironics, Inc. |
| May 1, 2023 | Trilogy Evo Universal Ventilator, Model Number DS2000X11B | The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventil... | Class I | Philips Respironics, Inc. |
| May 1, 2023 | Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B,... | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... | Class I | Philips Respironics, Inc. |
| May 1, 2023 | Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA220... | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... | Class I | Philips Respironics, Inc. |
| 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 5% from setpoint whe... | Class I | Philips Respironics, Inc. |
| Mar 1, 2023 | Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... | Class I | Philips Respironics, Inc. |
| Mar 1, 2023 | Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X... | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... | Class I | Philips Respironics, Inc. |
| Feb 10, 2023 | Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S... | A limited number of remediated Philips DreamStation units may experience communication issues whe... | Class I | Philips Respironics, Inc. |
| Dec 7, 2022 | Philips Garbin Ventilator, Model Number 1058180B | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Dec 7, 2022 | Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1... | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Dec 7, 2022 | Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U10... | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | Philips Respironics DreamWear Full Face Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | Therapy Mask 3100 NC/SP | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | Philips Respironics Amara View Minimal Contact Full-Face Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | DreamWisp Nasal Mask with Over the Nose Cushion | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.