Browse Device Recalls
725 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 725 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 725 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 6, 2015 | Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Com... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogr... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supp... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Com... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Comput... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessor... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomograp... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory device... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory device... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Compu... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accesso... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogra... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) C... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Comp... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Com... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) C... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) C... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed T... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 9, 2015 | Philips Healthcare DuraDiagnost X- Ray | The system is designed to emit a beep upon termination of an exposure. However, if the system ha... | Class II | Philips Medical Systems, Inc. |
| Feb 9, 2015 | Philips Healthcare DigitalDiagnost System X-Ray | The system is designed to emit a beep upon termination of an exposure. However, if the system ha... | Class II | Philips Medical Systems, Inc. |
| Feb 5, 2015 | Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce ... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce c... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technol... | Philips discovered that a software defect exists in marketed product wherein the sign indication ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cros... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produ... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. ... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence techn... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 3, 2015 | Philips Healthcare Allure BiPlane Series: Model 722013 Allura X... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare Xper cardio systems Model : 722123 Product Usage: T... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare Xper vascular system Model : 722124 Product Usage: ... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage:... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usa... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usa... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Feb 3, 2015 | Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usag... | Monitor Ceiling Suspension system may fall | Class II | Philips Medical Systems, Inc. |
| Jan 23, 2015 | Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Mode... | Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installatio... | Class II | Philips Medical Systems, Inc. |
| Dec 23, 2014 | HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, ... | MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to b... | Class II | Philips Medical Systems, Inc. |
| Dec 19, 2014 | Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are i... | Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification | Class II | Philips Medical Systems, Inc. |
| Dec 8, 2014 | Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit ... | Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion. | Class II | Philips Medical Systems (Cleveland) 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.