Browse Device Recalls

780 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 780 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 780 FDA device recalls.

Clear
DateProductReasonClassFirm
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
Apr 26, 2013 Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasi... On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier whi... Class II Heart Sync, Inc
Apr 26, 2013 Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic ... On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier whi... Class II Heart Sync, Inc
Mar 8, 2013 The LifeCare Pump Model 4200 PCA Infuser makes possible the practical impleme... Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... Class II Hospira Inc.
Feb 8, 2013 Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, ... There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ... Class I Medtronic Neuromodulation
Jan 24, 2013 D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Sy... The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207,... Class III Linvatec Corp. dba ConMed Linvatec
Jan 24, 2013 D3000I Advantage Drive System, 230v, surgical instrument motor. Product Us... The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207,... Class III Linvatec Corp. dba ConMed Linvatec
Dec 18, 2012 Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For t... The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of... Class I Ad-Tech Medical Instrument Corporation
Dec 11, 2012 GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performa... During electrical recertification testing it was found that the Voltage Scaling Board was non-con... Class II AMS Innovative Center - San Jose
Nov 9, 2012 Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in ... Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ... Class I Medtronic Neuromodulation
Nov 9, 2012 SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10... Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ... Class I Medtronic Neuromodulation
Nov 2, 2012 Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue)... Additional Warning Statement to prevent burns to the skin Class II Brookstone Company, Inc.
Sep 28, 2012 VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Resear... Potiential for a waste fluid overflow condition to accur while running decontamination cycles on ... Class II Ventana Medical Systems Inc
Sep 25, 2012 Belmont Rapid Infuser, a Fluid Management System, Model FMS2000. Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Po... Class II Belmont Instrument Corporation
Sep 19, 2012 S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 Sys... Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... Class II Sorin Group USA, Inc.
Sep 19, 2012 S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 Sy... Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... Class II Sorin Group USA, Inc.
Sep 19, 2012 S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 ... Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... Class II Sorin Group USA, 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.