Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in… An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in… An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in… An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in… An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by… An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in… An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum… An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall STANLEY Healthcare Arial 54315 Network Manager STANLEY Healthcare has received reports of outages on the Arial nurse call system. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Sur-vet Needle, 20G x 1” There is a potential for a loss of package integrity that may compromise the sterility of the product. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kansas, Kentucky, Massachusetts, Missouri, New Hampshire, Nevada, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Terumo Sur-vet Needle, 22G x 1” There is a potential for a loss of package integrity that may compromise the sterility of the product. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kansas, Kentucky, Massachusetts, Missouri, New Hampshire, Nevada, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Terumo Sur-vet Needle, 22G x 3/4” There is a potential for a loss of package integrity that may compromise the sterility of the product. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kansas, Kentucky, Massachusetts, Missouri, New Hampshire, Nevada, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Terumo Sur-vet Needle, 25G x 5/8” There is a potential for a loss of package integrity that may compromise the sterility of the product. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kansas, Kentucky, Massachusetts, Missouri, New Hampshire, Nevada, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Terumo Sur-vet Needle, 22G x 3/4” There is a potential for a loss of package integrity that may compromise the sterility of the product. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kansas, Kentucky, Massachusetts, Missouri, New Hampshire, Nevada, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Terumo Sur-vet Needle, 25G x 5/8” There is a potential for a loss of package integrity that may compromise the sterility of the product. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kansas, Kentucky, Massachusetts, Missouri, New Hampshire, Nevada, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Terumo Needle, 18G x 1” There is a potential for a loss of package integrity that may compromise the sterility of the product. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kansas, Kentucky, Massachusetts, Missouri, New Hampshire, Nevada, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Terumo Needle, 23G x 1” There is a potential for a loss of package integrity that may compromise the sterility of the product. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kansas, Kentucky, Massachusetts, Missouri, New Hampshire, Nevada, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Terumo Needle, 30G x 1/2” There is a potential for a loss of package integrity that may compromise the sterility of the product. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kansas, Kentucky, Massachusetts, Missouri, New Hampshire, Nevada, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall 3mL Luer-Lok Syringe The syringes have scale markings that were printed incorrectly. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereFlorida, Illinois, Kansas, Massachusetts, North Dakota, New Hampshire, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Virginia and Wisconsin
- Medical device recall 3mL Safety-Lok Syringe The syringes have scale markings that were printed incorrectly. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereFlorida, Illinois, Kansas, Massachusetts, North Dakota, New Hampshire, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Virginia and Wisconsin
- Medical device recall BrightView SPECT An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BrightView X An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BrightView XCT An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis FC A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis FA A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis MP A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis BC A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis BA A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis dBC A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis TA A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis dTA A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis dFC A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis dTC A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis dBA A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis dMP A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis dFA A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis dFC A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis TC A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis dBC A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee floor A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee ceiling A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee multi A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee biplane A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee floor MN A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee biplane MN A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zeego, Model Number 10280959 A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spacelabs Healthcare Smart Disclosure System Several reports were received that patient records were printed with the correct patient demographics but containing another patient’s waveforms. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monoject Standard Hypodermic Needle, 14 G x 1-1/2” Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusCompletedWhereNationwide
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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