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 |
|---|---|---|---|---|
| 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. |
| 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 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 19, 2019 | Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy E... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Tril... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is inte... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is int... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is i... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is inten... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is i... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Nov 19, 2019 | Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is ... | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW ... | Class I | Philips Respironics, Inc. |
| Jun 12, 2018 | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators... | In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for th... | 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.