Browse Device Recalls

1,677 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,677 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 1,677 FDA device recalls in MN.

Clear
DateProductReasonClassFirm
Apr 28, 2014 Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems O... Greatbatch identified that the documentation does not support the five-year shelf life of the Bar... Class II Greatbatch Medical
Apr 24, 2014 Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Pro... Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 1... Class II Mar Cor Purification
Apr 11, 2014 NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, N... Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used ... Class II Blue Belt Technologies MN
Apr 9, 2014 ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF:... Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a prod... Class II Ev3, Inc.
Apr 4, 2014 Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtr... Some refill kits in the affected lots may contain an extension tubing set that is occluded and he... Class II Medtronic Neuromodulation
Mar 31, 2014 Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized u... Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more fr... Class II NEO METRICS, INC.
Mar 17, 2014 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Ste... Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospita... Class II 3M Company - Health Care Business
Mar 14, 2014 InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 19241... Leak issues were discovered through accelerated age testing. Class II InterValve Inc
Mar 3, 2014 Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 3... The sterile pouch of the devices from this lot may not be completely sealed and sterility may be ... Class II Boston Scientific Corporation
Feb 27, 2014 Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including t... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), Restore... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 26, 2014 Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-... This recall provides important new information regarding overinfusion associated with the Medtron... Class II Medtronic Neuromodulation
Feb 19, 2014 Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and R... Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, ... Class II Gyrus Medical, Inc
Feb 4, 2014 Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H... Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA B... Class II Boston Scientific Corporation
Feb 4, 2014 Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter,... Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA B... Class II Boston Scientific Corporation
Jan 31, 2014 Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T1028... Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Imp... Class I Greatbatch Medical
Jan 31, 2014 Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: S... Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions from specific material nu... Class II Bock,Otto,Orthopedic Ind,Inc
Jan 30, 2014 Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 7882... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-V... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP ... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-V... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 27, 2014 CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-0... Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return o... Class III Cardiovascular Systems, Inc.
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 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular B... Specific lots of Imprint II and Paradigm impression material refill packs are being recalled beca... Class II 3M Company - Health Care Business
Oct 28, 2013 Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura sub... Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD ... Class II Synovis Surgical Innovations, Inc.
Oct 28, 2013 Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in pe... Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD ... Class II Synovis Surgical Innovations, Inc.
Oct 21, 2013 Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethyl... A Hand Piece high deployment force exceeded the maximum specification. Class II Urologix, Inc.
Oct 21, 2013 VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3... Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a... Class II Vital Images, Inc.
Oct 11, 2013 Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx o... St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary noti... Class II St. Jude Medical
Oct 11, 2013 US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path ... St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary noti... Class II St. Jude Medical
Sep 30, 2013 Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, mode... Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulat... Class II Medtronic Neuromodulation
Sep 30, 2013 Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program R... Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ... Class II Medtronic Neuromodulation
Sep 30, 2013 Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr... Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulat... Class II Medtronic Neuromodulation
Sep 30, 2013 Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr... Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ... Class II Medtronic Neuromodulation
Sep 10, 2013 Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Ve... Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable V... Class II Smiths Medical ASD, Inc.
Sep 10, 2013 Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away S... Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable V... Class II Smiths Medical ASD, Inc.
Aug 29, 2013 Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... Class II Boston Scientific CRM Corp
Aug 29, 2013 Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... Class II Boston Scientific CRM Corp
Aug 13, 2013 AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products ... Following the identification of the disassociation of an impactor tip during surgery, Tornier is ... Class II Tornier, Inc
Aug 5, 2013 3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and... 3M is conducting a voluntary product recall of selected lots of 3M" Scotchcast" Wet or Dry Cast P... Class II 3M Company - Health Care Business
Aug 5, 2013 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product co... 3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these prod... Class II 3M Company/3m Espe Dental Products
Jul 31, 2013 Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiatio... Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut... Class II Boston Scientific Corporation
Jul 31, 2013 Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irrad... Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut... Class II Boston Scientific Corporation
Jul 24, 2013 GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, St... On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated... Class II Gyrus Medical, Inc
Jul 24, 2013 Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 083104... Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they... Class II Nestle HealthCare Nutrition
Jul 19, 2013 Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile... Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system durin... Class II Blue Belt Technologies MN
Jul 17, 2013 Medtronic Custom Perfusion System with Trillium BioSurface (a polymer contain... Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... Class II Medtronic Inc. Cardiac Rhythm Disease Management

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.