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.

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DateProductReasonClassFirm
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.