Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a… Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Convertor Isolation Gown, AAMI Level 3 protection Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The… Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The… Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Allura Xper Systems (R7.6-R8.1) Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DiaSorin LIAISON Q.S.E.T Customer complaints were received alleging leaking devices and insufficient buffer volume. Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are… Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study. Class IIFDA’s classDec 18, 2024in FDA’s Enforcement Report15 statesnamed in where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Florida, Hawaii, Kentucky, Massachusetts, Maryland, Missouri, New Jersey, New York, Ohio, Tennessee, Texas, Virginia and Washington
- Medical device recall Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah… Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned… Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Idaho, Indiana, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee and West Virginia named
- Medical device recall Fusion Pro 24 a. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Non-ablative Fractional Laser Systems Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Diode Laser Hair Removal All model WLA-01 systems sold to US customers are found to have labeling non-compliances Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Ziehm Solo. Digital Mobile C-arm Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedDec 11, 2024ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall Ziehm Solo FD Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedDec 11, 2024ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall Ziehm Vision system, x-ray, tomography, computed. Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedDec 11, 2024ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall Ziehm Vision FD Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedDec 11, 2024ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall Ziehm Vision R Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedDec 11, 2024ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall Ziehm Vision RFD Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedDec 11, 2024ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall Ziehm Vision RFD 3D Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedDec 11, 2024ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall BIORAPTOR Suture Anchors Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Illinois, Indiana, Kentucky, Maryland, Minnesota, North Carolina, Nebraska, New Hampshire, New Jersey and Texas named
- Medical device recall Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Spectral CT and Spectral CT Plus Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Hawaii, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington and West Virginia named
- Medical device recall BD EpiCenter Single User Software Version or BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD EpiCenter Data Management System Version or BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD EpiCenter Data Management System, Multi User Software Version or BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD COR PX Instrument Version or BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD COR MX Instrument Version or BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD COR GX Instrument Version or BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD MAX System, BD MAX Instrument Version or BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Synapsys Informatics Solution (Laboratory Solution) Version or BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Phoenix M50 Automated Microbiology System Version or BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BACTEC FX, Instrument Top BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD BACTEC FX40 Instrument Version or BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BACTEC 9120 System Version or BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BACTEC 9240 System Version or BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CI Analyzer Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cartiva Synthetic Cartilage Implant (SCI) Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of… Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GE Healthcare Discovery RT GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Optima 520 GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Optima 680 Expert GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Revolution ACE GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Revolution Advance GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Revolution Ascend GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Revolution Ascend Elite GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Revolution Eagle GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Revolution EVO GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Revolution Frontier GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Revolution Maxima GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Revolution Maxima M GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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