Browse Device Recalls

3,629 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,629 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 3,629 FDA device recalls, Class I.

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DateProductReasonClassFirm
May 7, 2018 WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numb... When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle,... Class I Biosense Webster, Inc.
May 3, 2018 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-... Ingress of fluids into the device can affect various electronic circuit boards which would preven... Class I Maquet Datascope Corp - Cardiac Assist Division
May 2, 2018 Heartware Medtronic HVAD System for cardiac use. Including the following pa... Possible transient electrical connection interruption between an HVAD System power source (Batter... Class I Heartware
Apr 13, 2018 Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with F... The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bez... Class I CareFusion 303, Inc.
Apr 5, 2018 Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 1... Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlu... Class I Abbott
Mar 22, 2018 BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UD... BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... Class I Becton Dickinson & Company
Mar 22, 2018 BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 503829036... BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... Class I Becton Dickinson & Company
Mar 22, 2018 BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551) BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... Class I Becton Dickinson & Company
Mar 22, 2018 BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 5038... BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top ... Class I Becton Dickinson & Company
Mar 1, 2018 Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The pr... The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... Class I Draeger Medical, Inc.
Mar 1, 2018 Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: ... The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... Class I Draeger Medical, Inc.
Mar 1, 2018 Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The p... The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... Class I Draeger Medical, Inc.
Mar 1, 2018 Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The... The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... Class I Draeger Medical, Inc.
Feb 26, 2018 MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 3... There is a potential issue for all MindFrame Capture devices to partially detach or separate from... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Feb 19, 2018 EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable... Lack of adequate validation and controls to ensure that product cleanliness parameters were consi... Class I Zimmer Biomet, Inc.
Feb 19, 2018 SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-M... Lack of adequate validation and controls to ensure that product cleanliness parameters were consi... Class I Zimmer Biomet, Inc.
Jan 26, 2018 bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST ... Customer reports indicated an increase in the rate of non-detected MRSA in association with the V... Class I bioMerieux, Inc.
Jan 12, 2018 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 M... A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... Class I Beckman Coulter Inc.
Jan 12, 2018 COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM ... A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... Class I Beckman Coulter Inc.
Dec 19, 2017 ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GM... Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... Class I Ventana Medical Systems Inc
Dec 19, 2017 Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitr... Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... Class I Ventana Medical Systems Inc
Dec 19, 2017 iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157... Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... Class I Ventana Medical Systems Inc
Dec 19, 2017 NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche ... Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... Class I Ventana Medical Systems Inc
Dec 19, 2017 CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche G... Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... Class I Ventana Medical Systems Inc
Dec 19, 2017 ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 059... Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... Class I Ventana Medical Systems Inc
Dec 19, 2017 Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the fo... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 063965180... Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... Class I Ventana Medical Systems Inc
Dec 19, 2017 ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI ... Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... Class I Ventana Medical Systems Inc
Dec 19, 2017 Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the followi... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. V... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as ... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the ... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06... Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... Class I Ventana Medical Systems Inc
Dec 19, 2017 OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMM... Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... Class I Ventana Medical Systems Inc
Dec 19, 2017 OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396... Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... Class I Ventana Medical Systems Inc
Dec 19, 2017 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Label... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 0527196... Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dis... Class I Ventana Medical Systems Inc
Dec 19, 2017 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Label... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Label... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 4, 2017 LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e... Physio-Control is aware that some devices have had power-related failures as customers prepared t... Class I Physio-Control, Inc.
Oct 27, 2017 LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009 ... The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing... Class I Physio-Control, Inc.
Oct 27, 2017 LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-00... The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing... Class I Physio-Control, Inc.
Oct 11, 2017 Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and ... Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical venti... Class I Spacelabs Healthcare, Ltd.
Oct 5, 2017 MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation. The firm received complaints that involved an unanticipated interaction between a NeuroBlate syst... Class I Monteris Medical Corp
Sep 26, 2017 6F Taiga Guiding Catheter Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. Class I Medtronic Inc
Sep 5, 2017 Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...
Sep 5, 2017 Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Class I Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi...

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.