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 7, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report48 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusCompletedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030,… Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report48 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusCompletedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report48 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusCompletedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Boston Scientific The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous… Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereCalifornia, Michigan, Mississippi, North Carolina, Ohio, Tennessee and West Virginia
- Medical device recall MYNXGRIP 6F/7F Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereCalifornia, Michigan, Mississippi, North Carolina, Ohio, Tennessee and West Virginia
- Medical device recall BD Recanalization System Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report34 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Virginia and Wisconsin
- Medical device recall BrightView, Gamma Camera System While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BrightView X, Gamma Camera While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BrightView XCT, Gamma Camera While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alinity i Processing Module The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report48 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Alinity c Processing Module The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report48 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall ARCHITECT c4000 Processing Module The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report48 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Sensis Vibe Hemo The possibility of the Sensis documentation functionality application to crash. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereCalifornia, Connecticut and Florida
- Medical device recall Model No. CYF-5, Cystonephrofiberscope Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Model No. CYF-5R, Cystonephrofiberscope Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Model No. BF-P190, EVIS EXERA III Bronchovideoscope Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Model No. BF-XP190, EVIS EXERA III Bronchovideoscope Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Model No. CYF-V2, VISERA Cysto-Nephro Videoscope Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System. New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NIM TriVantage EMG Endotracheal Tubes Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring, Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Olympus ENDOEYE HD II Rigid Videoscope Reports of a pink or green coloration of the image. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona and California named
- Medical device recall Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona and California named
- Medical device recall VADER pedicle system, torque wrench icotec has received notification of one revision that had to be carried out because nut screws had become loose. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereArizona, California, Colorado, Delaware, Michigan, North Carolina, New York, Ohio, Pennsylvania and Texas
- Medical device recall VADER pedicle system, torque wrench icotec has received notification of one revision that had to be carried out because nut screws had become loose. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereArizona, California, Colorado, Delaware, Michigan, North Carolina, New York, Ohio, Pennsylvania and Texas
- Medical device recall Detector H. Pylori, Catalog Number IHP-30 Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereCalifornia and Missouri
- Medical device recall BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro… A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report16 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Florida, Iowa, Illinois, Kansas, Massachusetts, Maryland, Missouri, North Carolina, Nebraska, New Jersey, Ohio, Tennessee, Texas and Utah
- Medical device recall The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with… A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report16 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Florida, Iowa, Illinois, Kansas, Massachusetts, Maryland, Missouri, North Carolina, Nebraska, New Jersey, Ohio, Tennessee, Texas and Utah
- Medical device recall Q-Stress Cardiac Stress Testing System, version 6, with below product name / Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereGeorgia and Puerto Rico
- Medical device recall XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN… Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereGeorgia and Puerto Rico
- Medical device recall XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT… Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereGeorgia and Puerto Rico
- Medical device recall CORI REAL INTELLIGENCE Robotic Drill, Product No Possibility that the user is unable to resolve drill disconnection error messages. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown) Surgical gowns were manufactured with the wrong sleeve. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereMaryland, Ohio, Tennessee, Texas and Wisconsin
- Medical device recall QMS Tacrolimus Calibrators Ortho-Clinical Diagnostics, Inc. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereFlorida, Illinois, Indiana, New Jersey, New Mexico and Texas
- Medical device recall Scoot Control R-net, Product Number P015-61 In rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come back to its neutral point by itself. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereTennessee and Texas
- Medical device recall Ambu aView 2 A Monitor Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a… Class IIFDA’s classJan 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall (1) Ingenia Ambition X (Product Number 781356) The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. Class IIFDA’s classJan 17, 2024in FDA’s Enforcement Report24 statesnamed in where it went PublishedJan 17, 2024ClassClass IIStatusOngoingWhereCalifornia, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maine, Michigan, Missouri, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Vermont, Wisconsin and Wyoming
- Medical device recall Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current) The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 10, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Regard Dressing change kit ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 10, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 10, 2024ClassClass IStatusTerminatedWhereNationwide, and Louisiana 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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