Browse Device Recalls

723 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 723 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 723 FDA device recalls.

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DateProductReasonClassFirm
Oct 7, 2015 Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartb... Class II Cyberonics, Inc
Sep 3, 2015 Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80... When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and i... Class II Spacelabs Healthcare Inc
Jul 23, 2015 Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response Sy... Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging. Class II Lifeline Systems, Incorporated
Jul 13, 2015 PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended fo... The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V... Class I Draeger Medical, Inc.
Jul 1, 2015 Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical p... Saw head separated from the drive unit or began to come loose. Class II The Anspach Effort, Inc.
May 1, 2015 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Pe... Terumo CVS is implementing field correction activities to address the identified causes of the Te... Class II Terumo Cardiovascular Systems Corporation
May 1, 2015 Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Pe... Terumo CVS is implementing field correction activities to address the identified causes of the Te... Class II Terumo Cardiovascular Systems Corporation
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 ... Complaints with the HVAD Internal Controller Alarm Battery failures. Class I HeartWare Inc
Apr 13, 2015 GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5... Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibil... Class II Verathon, Inc.
Mar 25, 2015 Universal Charger Product Usage: The Stryker Universal Battery Charg... The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as desi... Class III Stryker Instruments Div. of Stryker Corporation
Mar 24, 2015 Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532... The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive... Class II The Anspach Effort, Inc.
Mar 17, 2015 Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product... Possible performance issue when used with specific AA-sized (LR6) batteries. The negative termina... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Mar 16, 2015 Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 ... Battery packs may heat up abnormally and ignite in rare instance. Class II Arcos, Inc
Mar 10, 2015 FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MO... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 6, 2015 Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devi... 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 6 (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 TF (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 X (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 CardioMD III (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 Diamond Select Brilliance CT 16 (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 GEMINI TF PET/CT 16 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 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 VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Gener... The pulse generators have a lower battery longevity than specified in their design requirement as... Class II Cyberonics, 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

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.