Medical devices
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2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, 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.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3,… Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm Due a design issue where the navigated array connection geometry is incorrect. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Illinois, Indiana, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Tennessee, Texas and Virginia named
- Medical device recall ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm Due a design issue where the navigated array connection geometry is incorrect. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Illinois, Indiana, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Tennessee, Texas and Virginia named
- Medical device recall Azurion 3 M12 System Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 3 M15 System Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 B12 System Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 B20 System Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 M12 System Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 M20 System Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 5 M12 System Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 5 M20 System Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000 Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nevada, New York, South Carolina, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Surepulse VS Cap Extra Small Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. Class IIIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 18, 2026ClassClass IIIStatusOngoingWhereNationwide, and Connecticut and Texas named
- Medical device recall Surepulse VS Cap Small Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. Class IIIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 18, 2026ClassClass IIIStatusOngoingWhereNationwide, and Connecticut and Texas named
- Medical device recall Surepulse VS Cap Medium Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. Class IIIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 18, 2026ClassClass IIIStatusOngoingWhereNationwide, and Connecticut and Texas named
- Medical device recall Surepulse VS Cap Large Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. Class IIIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 18, 2026ClassClass IIIStatusOngoingWhereNationwide, and Connecticut and Texas named
- Medical device recall Surepulse VS Cap Extra Large Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor. Class IIIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 18, 2026ClassClass IIIStatusOngoingWhereNationwide, and Connecticut and Texas named
- Medical device recall Barco MNA with the HexaVue IP Integration System This is a sub-recall of event RES 96885. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, North Carolina, New York, Ohio, Tennessee, Texas and Virginia named
- Medical device recall AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm Increased reports of stent deployment and expansion issues. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 11, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm Increased reports of stent deployment and expansion issues. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 11, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm Increased reports of stent deployment and expansion issues. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 11, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm Increased reports of stent deployment and expansion issues. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 11, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm Increased reports of stent deployment and expansion issues. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 11, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm Increased reports of stent deployment and expansion issues. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 11, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall COULTER DxH Diluent Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife… A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRISMAFLEX ST100 SET US There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRISMAFLEX ST150 SET US There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRIMSAFLEX M100 SET There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRISMAFLEX M150 SET There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRISMAFLEX HF1000 SET There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRISMAFLEX HF1000 SET There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRISMAFLEX TPE2000 SET There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement Report30 statesnamed in where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereAlabama, Arkansas, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall EMPOWR 3D Knee Tibial Insert 5R 14MM, VE 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement Report14 statesnamed in where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereAlabama, California, Iowa, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island and Texas
- Medical device recall EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement Report14 statesnamed in where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereAlabama, California, Iowa, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island and Texas
- Medical device recall CellMek SPS Sample Preparation System Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Illinois, Massachusetts, Missouri, Oregon and Washington named
- Medical device recall VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n)… Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE A specific lot of screws is incorrectly labeled. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MiniMed 780G Insulin Pump A software timing and processor communication issue in MiniMed” 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement Report45 statesnamed in where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT… To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT… To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities… To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities… To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Focalyx Fusion Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function… Class IIFDA’s classFeb 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Massachusetts and New York 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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