Browse Device Recalls
46 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 46 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 46 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| Jan 6, 2021 | PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663... | Due to unqualified "design verification" batteries being shipped to customers. | Class II | Respironics California, LLC |
| 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 |
| 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 |
| Mar 5, 2020 | Philips V60 Ventilators with Power Management PCBA part number 1055906 | Solder connection failure on Power Management printed circuit board assembly of ventilators may c... | Class II | Respironics California, LLC |
| Sep 11, 2019 | Respironics V680 Ventilator, Service # 850011, (OUS Only) | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... | Class II | Respironics California, LLC |
| Sep 11, 2019 | Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 45... | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... | Class II | Respironics California, LLC |
| Sep 11, 2019 | Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP... | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... | Class II | Respironics California, LLC |
| Sep 11, 2019 | Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617,... | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... | 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.