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 6, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then… Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU Class IIFDA’s classOct 23, 2024in FDA’s Enforcement Report15 statesnamed in where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Massachusetts, Michigan, Missouri, North Dakota, New York, Ohio, Pennsylvania and Texas
- Medical device recall MEDLINE HEART CABG CDS Medline Industries, LP. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE HEART OVERHEAD TABLE PACK Medline Industries, LP. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE OPEN HEART PACK Medline Industries, LP. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE OPEN HEART Medline Industries, LP. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE KIT CV I II Medline Industries, LP. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE OPEN HEART NIMC KIT Medline Industries, LP. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm Spinal fixation system implant screws marked “DNI” are not intended to be implanted and may not have been manufactured in accordance with released… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, Michigan, Missouri, Ohio, Pennsylvania, Texas, Virginia and Wisconsin named
- Medical device recall Change Healthcare Cardiology Hemo A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations,… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Horizon Cardiology Hemo A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations,… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall McKesson Cardiology Hemo A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations,… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: NOVA ORTHO-MED INC Firm identified a potential risk for a fall hazard. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: NOVA ORTHO-MED INC Firm identified a potential risk for a fall hazard. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Brand Name: NOVA ORTHO-MED INC Firm identified a potential risk for a fall hazard. Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Vanta Implantable Neurostimulator (INS) Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated… Class IIFDA’s classOct 23, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 23, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Z-800 Infusion System There is a defect in the air-in-line software algorithm. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2… Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque… Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton),… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and California and Virginia named
- Medical device recall FastPack TSH Calibrator Kit Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereAlaska, Alabama, Georgia, Iowa, Kansas, Massachusetts, Minnesota, Mississippi, Montana, North Carolina, Nebraska, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented… Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Florida, North Carolina, New Jersey, Ohio, Pennsylvania, Tennessee and Wisconsin named
- Medical device recall iCast Covered Stent, 6MMx16MMx120CM There is an error in the Unique Device Identifier (UDI) printed on the product’s distribution label. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Massachusetts, Michigan, Ohio and Washington named
- Medical device recall Beckman Coulter Dxl 9000 Access Immunoassay Analyzer When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereFlorida, Georgia, Indiana, Kansas, New Hampshire, New Jersey, Oklahoma, Pennsylvania and Texas
- Medical device recall BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone… Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will… Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Aligned Medical Tonsil Tray Due to convenience kits containing a kit component that is under a recall action for improper use. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Missouri, Ohio, Virginia and Wyoming named
- Medical device recall Aligned Medical Tonsil ENT Pack Due to convenience kits containing a kit component that is under a recall action for improper use. Class IIFDA’s classOct 16, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 16, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Missouri, Ohio, Virginia and Wyoming 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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