Browse Device Recalls

4,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,602 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 4,602 FDA device recalls in CA.

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DateProductReasonClassFirm
Jul 10, 2019 Logolas Laser Projection Series The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... Class II Gk Photonics Inc
Jul 10, 2019 Burstberry Laser Projection Series The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully compl... Class II Gk Photonics Inc
Jul 9, 2019 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... The action has been initiated to address reports of burst balloons which have resulted in signifi... Class I Edwards Lifesciences, LLC
Jul 9, 2019 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... The action has been initiated to address reports of burst balloons which have resulted in signifi... Class I Edwards Lifesciences, LLC
Jul 9, 2019 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... The action has been initiated to address reports of burst balloons which have resulted in signifi... Class I Edwards Lifesciences, LLC
Jul 9, 2019 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Deliv... The action has been initiated to address reports of burst balloons which have resulted in signifi... Class I Edwards Lifesciences, LLC
Jul 8, 2019 BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The ... The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable we... Class II Becton, Dickinson and Company, BD Biosciences
Jul 8, 2019 BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III i... The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable we... Class II Becton, Dickinson and Company, BD Biosciences
Jul 8, 2019 BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSC... The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encou... Class II Becton, Dickinson and Company, BD Biosciences
Jul 3, 2019 CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Elect... Possible mis-labeling of the device with incorrect serial number labels which may result in a pat... Class II Capso Vision, Inc.
Jul 1, 2019 Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 1163456... Calibration; it has been determined that the capnographs may have been calibrated during manufact... Class II CareFusion 303, Inc.
Jul 1, 2019 daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI... The firm became aware of a manufacturing variation in which black and green reloads in select Sta... Class II Intuitive Surgical, Inc.
Jul 1, 2019 daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UD... The firm became aware of a manufacturing variation in which black and green reloads in select Sta... Class II Intuitive Surgical, Inc.
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-523 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT... The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-722 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 MiniMed Paradigm Model 511 Insulin Pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 MiniMed Paradigm Insulin pump, model number MMT-712 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 MiniMed Paradigm 512 Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-522 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 MiniMed Insulin Pump, model # MMT-508 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-723 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 25, 2019 MAGEC 1 System Safety Alert to all surgeons informing them of post-implantation fractures of an internal metalli... Class II NuVasive Specialized Orthopedics, Inc.
Jun 20, 2019 ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: ... Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: ... Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: ... Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 20, 2019 ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum... Class I St Jude Medical Inc.
Jun 17, 2019 da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601... One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. Th... Class II Intuitive Surgical, Inc.
Jun 12, 2019 SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Pr... The firm has identified that cross-reactivity testing may not meet the claims indicated in the Ba... Class II Beckman Coulter Inc.
May 30, 2019 Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is i... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Elec... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Elec... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is i... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is ind... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 28, 2019 Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747... Packaged dental implant healing abutments were found to contain the wrong size device. Class II Nobel Biocare Usa Llc
May 23, 2019 Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software v... During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscr... Class II Obalon Therapeutics Inc
May 20, 2019 Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used... Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad o... Class II Medtronic Inc.
May 17, 2019 Beckman Coulter Power Express Sample Processing System AU5800XL connection un... Potential exposure to biohazard. Software design problem causes excess speed and vibrations in... Class II Beckman Coulter Inc.
May 16, 2019 GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm). Incorrect coil length on the label Class II Codman & Shurtleff Inc
May 14, 2019 IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.... Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during c... Class I Edwards Lifesciences, LLC
May 9, 2019 Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald i... The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner an... Class II Abbott Laboratories

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.