Browse Device Recalls

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

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DateProductReasonClassFirm
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
May 1, 2019 Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601... Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunc... Class II Abbott Vascular
Apr 30, 2019 Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 338... The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL)... Class II Beckman Coulter Inc.
Apr 30, 2019 Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II,... The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL... Class II Beckman Coulter Inc.
Apr 30, 2019 Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, ... The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL... Class II Beckman Coulter Inc.
Apr 30, 2019 Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (... The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL... Class II Beckman Coulter Inc.
Apr 30, 2019 Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen ... The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL... Class II Beckman Coulter Inc.
Apr 30, 2019 Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine ... The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL)... Class II Beckman Coulter Inc.
Apr 24, 2019 ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: Th... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 Flexible Intubation Fiberscope, Model # 11301AB1 The action is being initiated due to intubation scopes improperly manufactured with a double por... Class II Karl Storz Endoscopy
Apr 24, 2019 Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Produ... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Prod... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads fun... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Pack... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 23, 2019 Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufa... There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not at... Class II Stryker Corporation

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.