Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, 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.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing. Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Steripath Gen2 Blood Collection System Due to an uptick of complaints associated with premature needle retraction of blood collection system. Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedDec 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, Montana, Nebraska, New Mexico, New York, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia and Wyoming named
- Medical device recall NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That… Class IIFDA’s classDec 8, 2021in FDA’s Enforcement Report47 statesnamed in where it went PublishedDec 8, 2021ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the… Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the… Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the… Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the… Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the… Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the… Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the… Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the… Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high… Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Oregon, Pennsylvania, Washington and West Virginia named
- Medical device recall GE Centricity Universal Viewer Zero Footprint Client There is a potential to display incomplete patient imaging study. Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedDec 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington and West Virginia named
- Medical device recall Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as… Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as… Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost C90 The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ProxiDiagnost N90 is multi-functional general R/F systems. The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CombiDiagnost R90 is multi-functional general R/F systems. The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition The accumulated dose is incorrectly displayed in certain situations. Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roberts Digital VIPR System (with E-size cylinder) VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke Class IIFDA’s classDec 1, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereConnecticut, Maryland, Montana and Ohio
- Medical device recall Western Oxytote DTE Digital VIPR (head only) VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke Class IIFDA’s classDec 1, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereConnecticut, Maryland, Montana and Ohio
- Medical device recall Western Oxytote DTE Digital VIPR System (with D-size cylinder) VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke Class IIFDA’s classDec 1, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereConnecticut, Maryland, Montana and Ohio
- Medical device recall Western Oxytote DTE Digital VIPR System (with E-size cylinder) VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke Class IIFDA’s classDec 1, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereConnecticut, Maryland, Montana and Ohio
- Medical device recall ARCHITECT i1000SR Twelve software-related issues affecting software version 9.41 and earlier were identified. Class IIFDA’s classDec 1, 2021in FDA’s Enforcement Report50 statesnamed in where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, 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 Twelve software-related issues affecting software version 9.41 and earlier were identified. Class IIFDA’s classDec 1, 2021in FDA’s Enforcement Report50 statesnamed in where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, 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 Cardioblate CryoFlex Surgical Ablation Console There is potential for intermittent electrical connectivity between the console and probe. Class IIFDA’s classDec 1, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereIllinois, Kansas and Utah
- Medical device recall Freelite Human Lambda Free Kit (for use on the SPAPLUS) Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement Report13 statesnamed in where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Michigan, New York, Oklahoma, South Dakota, Texas and Virginia
- Medical device recall The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon… Incorrect expiration date on its package labeling (shipper box and inner carton label). Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Missouri, North Carolina, Ohio, Texas, Utah and Wisconsin named
- Medical device recall HemosIL ReadiPlasTin The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Iowa, Illinois, Kansas, Maine, Michigan, North Carolina, New York, Oklahoma, South Carolina and Virginia named
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209… Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Maine and Texas named
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410… Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Maine and Texas named
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number:… Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Maine and Texas named
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470… Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Maine and Texas named
- Medical device recall Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471… Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Maine and Texas named
- Medical device recall Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic… The processing of collected episode data may fail due to a software error. Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SOMATOM Force with software syngo.CT VB20 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition AS with software syngo.CT VB20 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition Edge with software syngo.CT VB20 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition Flash with software syngo.CT VB20 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Drive with software syngo.CT VB20 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Confidence with software syngo.CT VB20 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Edge Plus with software syngo.CT VB20 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and West Virginia named
- Medical device recall Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF… Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube. Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and West Virginia named
- Medical device recall Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF… Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube. Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and West Virginia named
- Medical device recall Medtronic Wireless Recharger The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic Wireless Recharger The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient… Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 1, 2021ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico 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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