Browse Device Recalls
797 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 797 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 797 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 10, 2015 | Carto 3 EP Navigation System. Electro physiology system which views of the el... | Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed... | Class II | Biosense Webster, Inc. |
| Jul 8, 2015 | Medline Electrical Clipper with Charging base The Electrical Surgical Cli... | Charging base of surgical clippers overheats and smokes. | Class II | Medline Industries Inc |
| Jun 12, 2015 | ASP-1020 LipoTower with Aspiration Pump. Medical use. | There is potential risk of electrical shock if lead wires inside the device become detached and t... | Class II | MicroAire Surgical Instruments, LLC |
| Jun 12, 2015 | ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use. | There is potential risk of electrical shock if lead wires inside the device become detached and t... | Class II | MicroAire Surgical Instruments, LLC |
| Apr 29, 2015 | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Produ... | Failures of the splice repair kit if exposed to excessive force. | Class I | HeartWare Inc |
| Apr 2, 2015 | Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Di... | Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been inst... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 19, 2015 | Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography syst... | potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connectio... | Class II | Siemens Medical Solutions USA, 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 |
| Feb 24, 2015 | Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electro... | The electrodes may fail to transmit signals. | Class II | Leonhard Lang Medizintechnik GmbH |
| Feb 19, 2015 | Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove ... | Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electri... | Class II | Steris Corporation |
| Jan 9, 2015 | The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable de... | Current labeling indicates that cycling improves device longevity in every programming scenario. ... | Class II | Medtronic Neuromodulation |
| Nov 21, 2014 | Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek ... | Affected product may have compromised sterility due to packaging defects. It was determined that ... | Class II | Atricure Inc |
| Nov 19, 2014 | ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside ... | When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor... | Class II | Philips Electronics North America Corporation |
| Oct 29, 2014 | Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V... | If the power supply fan mounting screws are installed incorrectly, the ends of the screws may tou... | Class II | Respironics California Inc |
| Oct 22, 2014 | Philips Expression MR200 MRI Patient Monitoring System. | The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; po... | Class II | Invivo Corporation |
| Oct 9, 2014 | Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System | If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light h... | Class II | Cynosure, Inc. |
| Sep 17, 2014 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... | Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... | Class II | Boston Scientific CRM Corp |
| Sep 17, 2014 | Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Gene... | A failure of a specific component may prevent the ventilators from operating on AC power or trans... | Class I | Respironics California Inc |
| Jul 25, 2014 | SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for t... | The integrity of the wires inside main electrical chord become compromised from excessive flexing... | Class II | JK Products & Services, Inc |
| Jul 14, 2014 | Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, S... | Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potent... | Class II | Medtronic Neuromodulation |
| Jul 11, 2014 | FlowCOUPLER. An implantable device that is used to detect blood flow in ves... | Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some un... | Class II | Baxter Healthcare Corporation |
| May 13, 2014 | The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-co... | The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may ha... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 13, 2014 | The NAV3i Platform Power Box supplies the electrical components with power (e... | The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may ha... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Apr 29, 2014 | Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Gene... | Events related to a pacing rate outside of the intended setting, including events of sudden incre... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Apr 16, 2014 | Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use wi... | Integra LifeSciences has identified through a small number of complaints that some lot numbers of... | Class II | Integra LifeSciences Corp. |
| Apr 14, 2014 | Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor ... | A small number of Vista Air Compressors were miswired, which if installed and powered up, could c... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2014 | ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients... | There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and ... | Class II | Arjo Hospital Equipment AB |
| Mar 7, 2014 | Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc... | One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp whi... | Class II | Clarity Medical Systems Inc |
| Mar 5, 2014 | FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. El... | Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically... | Class II | Remington Medical Inc. |
| Feb 6, 2014 | Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 ... | Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed C... | Class II | Philips Medical Systems North America Inc. |
| Jan 24, 2014 | NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Cont... | NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC ... | Class II | Hologic, Inc |
| Dec 19, 2013 | Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with S... | Sterility cannot be guaranteed. | Class II | Teleflex Medical |
| Dec 19, 2013 | Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with S... | Sterility cannot be guaranteed. | Class II | Teleflex Medical |
| Nov 22, 2013 | Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pu... | Smiths Medical is conducting a recall involving all Medfusion¿ 4000 Syringe Infusion Pumps. Smi... | Class II | Smiths Medical ASD, Inc. |
| Nov 21, 2013 | The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. ... | Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 80... | Class II | Welch Allyn Protocol, Inc |
| Oct 2, 2013 | The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low powe... | The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. ... | Class II | EKOS Corporation |
| Oct 2, 2013 | REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance Syste... | It was discovered that the silicone potting failed to properly cure after undergoing the prescrib... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Sep 27, 2013 | Breeze C Scooter is a motorized electric scooter for elderly people. Brand ... | Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it... | Class II | S.A.E. AFIKIM |
| Sep 10, 2013 | Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar ... | Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did... | Class II | Aesculap, Inc. |
| Aug 15, 2013 | Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Me... | Dr¿ger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained... | Class II | Steris Corporation |
| Aug 14, 2013 | Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product... | During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia mach... | Class I | Draeger Medical, Inc. |
| Jul 30, 2013 | Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product U... | Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series e... | Class II | Getinge Disinfection |
| Jun 3, 2013 | Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ... | Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2... | Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... | Class I | Medtronic Neuromodulation |
| May 31, 2013 | BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, use... | Electrical power module installed on some in vitro diagnostic instruments does not meet industry ... | Class III | Becton Dickinson & Co. |
| May 6, 2013 | VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage:... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2013 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product cod... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2013 | VITROS 5600 Integrated System (product code 6802413) Product Usage: For ... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2013 | 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 F... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2013 | ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ S... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
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.