Browse Device Recalls
3,461 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,461 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 3,461 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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... |
| Sep 5, 2017 | Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ | 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 Unit Dose 15 ml Normal Saline ¿ | 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 550 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 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 | 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 | Portex 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 | Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | 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 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | 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... |
| Aug 28, 2017 | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Nu... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 28, 2017 | Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: ... | The device may exhibit premature battery depletion. | Class I | St Jude Medical Inc. |
| Aug 8, 2017 | Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. ... | Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecti... | Class I | Leonhard Lang Medizintechnik GmbH |
| Aug 7, 2017 | Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Gu... | Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a pot... | Class I | Spectranetics Corporation |
| Aug 2, 2017 | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter wit... | Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has ha... | Class I | OriGen Biomedical, Inc. |
| Jul 21, 2017 | Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9... | A component in the Certitude Loader may have a molding overflow defect that could detach during ... | Class I | Edwards Lifesciences, LLC |
| Jul 17, 2017 | CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 17, 2017 | CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle ... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
| Jul 17, 2017 | CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... | False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... | Class I | Maquet Datascope Corp - Cardiac Assist Division |
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.