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 |
|---|---|---|---|---|
| Nov 2, 2020 | Philips Respironics V60 Ventilator Part Number 1053615 - 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 1053618 - 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 R1076709 - Product Usage: inte... | Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: inte... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: ... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: inte... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: inte... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: int... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: ... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| Oct 30, 2020 | Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: inten... | Ventilator may experience potential issues with the backup battery failures: 1) if the battery is... | Class II | Respironics California, LLC |
| 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. |
| Jan 18, 2016 | Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbi... | Software Issue | Class II | Philips Respironics |
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.