Browse Device Recalls
135 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 135 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 135 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Sep 6, 2022 | Wisp and Wisp Youth Nasal Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation suppo... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for p... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide ... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive v... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support ... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for p... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Feb 28, 2022 | Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, ... | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... | Class I | Respironics California, LLC |
| Feb 28, 2022 | Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137... | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... | Class I | Respironics California, LLC |
| Feb 28, 2022 | Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (8500... | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, t... | Class I | Respironics California, LLC |
| Jan 24, 2022 | Philips Respironics V60 Ventilator Part Number 1053617 | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a br... | Class I | Respironics California, LLC |
| Jan 24, 2022 | Philips Respironics V60 Plus Ventilator Part Number 1138747 | A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a br... | Class I | Respironics California, LLC |
| Dec 22, 2021 | Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135... | Philips has identified a specific lot of non-conforming material manufactured by one of its suppl... | Class I | Philips Respironics, Inc. |
| Dec 22, 2021 | Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The ... | Philips has identified a specific lot of non-conforming material manufactured by one of its suppl... | Class I | Philips Respironics, Inc. |
| Jul 26, 2021 | Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, ... | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15... | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jul 26, 2021 | Trilogy Evo Universal, Product number DS2000X11B | Two software issues have been identified related to pressure increase in the device: The first is... | Class II | Philips Respironics, Inc. |
| Jun 18, 2021 | Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. T... | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... | Class I | Respironics California, LLC |
| Jun 18, 2021 | Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10.... | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... | Class I | Respironics California, LLC |
| Jun 14, 2021 | DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Ser... | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... | Class I | Philips Respironics, Inc. |
| Jun 14, 2021 | A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Conti... | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... | Class I | Philips Respironics, Inc. |
| Jun 14, 2021 | SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, R... | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... | Class I | Philips Respironics, Inc. |
| Jun 14, 2021 | Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Venti... | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... | Class I | Philips Respironics, Inc. |
| Jun 14, 2021 | A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Suppo... | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... | Class I | Philips Respironics, Inc. |
| Jun 14, 2021 | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... | Class I | Philips Respironics, Inc. |
| Apr 6, 2021 | BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Materi... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Numbe... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Numb... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Mat... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Numb... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Apr 6, 2021 | BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Mat... | Certain devices were built with motor assemblies that could contain non-conforming plastic materi... | Class II | Philips Respironics, Inc. |
| Nov 2, 2020 | Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: inten... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Nov 2, 2020 | Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: inten... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Nov 2, 2020 | Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: ... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Nov 2, 2020 | Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: int... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Nov 2, 2020 | Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: inten... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Nov 2, 2020 | Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: inten... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Nov 2, 2020 | Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: inten... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Nov 2, 2020 | Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: ... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Nov 2, 2020 | Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: inten... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Nov 2, 2020 | Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: inten... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Nov 2, 2020 | Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: inte... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Nov 2, 2020 | Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: inten... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Nov 2, 2020 | Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: inten... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
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.