Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Monoject Bluntfill with Filter, 18G x 1-1/2” Non-sterile product was shipped to customers. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Econocare Plus Overlay Item: 1025EC Due to a nonconformance of product contamination (human blood) of Econocare Plus Waffle Overlay products with the (master) lot # 932213A that may affect a… Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the… Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Randox Laboratories Ltd The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls… Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Indiana, Kansas, Michigan, Minnesota, North Carolina, Nebraska, Oklahoma and South Carolina named
- Medical device recall RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportTennesseethe one state its words name PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportTennesseethe one state its words name PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportTennesseethe one state its words name PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportTennesseethe one state its words name PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportTennesseethe one state its words name PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportTennesseethe one state its words name PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportTennesseethe one state its words name PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use A deterioration of performance was identified with influenza type B Enzyme Immunoassay Kits with findings of a positive bias with kit controls. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Minnesota, Missouri, North Carolina, Virginia and Washington named
- Medical device recall NeuraGen Nerve Guide, 7mm diameter, 2cm length Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use. Class IIIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMar 18, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New Mexico, New York, Pennsylvania, South Carolina and Texas named
- Medical device recall GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03 A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of low level disinfection for the reusable video laryngoscope,… Class IIFDA’s classMar 18, 2020in FDA’s Enforcement Report33 statesnamed in where it went PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Maryland, Michigan, Minnesota, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Pedicle Screws, multiple sizes, Article Nos An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw… Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Georgia, Louisiana, Ohio and Rhode Island named
- Medical device recall Iliac Screws, multiple sizes, Article Nos An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw… Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Georgia, Louisiana, Ohio and Rhode Island named
- Medical device recall Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from… Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall QIAGEN Rotor Gene Q Software version 2.3.4 When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a… Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cordis POWERFLEX P3, PTA Dilation Catheter Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 55 states named PublishedMar 11, 2020ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CareFusion Alaris Pump Module 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 55 states named PublishedMar 11, 2020ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CareFusion Alaris Syringe Module 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 55 states named PublishedMar 11, 2020ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CareFusion Alaris PCA Module 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 55 states named PublishedMar 11, 2020ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation… Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as… Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Revaclear Capillary Dialyzer 300 There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeRoyal Sterile Custom Kits containing Cardinal Health Gowns Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNew Jersey and Rhode Island
- Medical device recall DeRoyal Sterile Custom Kits containing Cardinal Health Gowns Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNew Jersey and Rhode Island
- Medical device recall DeRoyal Sterile Custom Kits containing Cardinal Health Gowns Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNew Jersey and Rhode Island
- Medical device recall DeRoyal Sterile Custom Kits containing Cardinal Health Gowns Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNew Jersey and Rhode Island
- Medical device recall DeRoyal Sterile Custom Kits containing Cardinal Health Gowns Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNew Jersey and Rhode Island
- Medical device recall DeRoyal Sterile Custom Kits containing Cardinal Health Gowns Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNew Jersey and Rhode Island
- Medical device recall DeRoyal Sterile Custom Kits containing Cardinal Health Gowns Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNew Jersey and Rhode Island
- Medical device recall DeRoyal Sterile Custom Kits containing Cardinal Health Gowns Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNew Jersey and Rhode Island
- Medical device recall DeRoyal Sterile Custom Kits containing Cardinal Health Gowns Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNew Jersey and Rhode Island
- Medical device recall DeRoyal Sterile Custom Kits containing Cardinal Health Gowns Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereNew Jersey and Rhode Island
- Medical device recall AIA-360 Automated Immunoassay Analyzer A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument… Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereArizona, Nebraska, New Jersey, New York and Washington
- Medical device recall Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 Some lots ending in “17”, “18”, “19”, or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which… Class IIFDA’s classMar 11, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Enzymatic Creatinine Reagent (CR-E 2 X 200) It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if… Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report48 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, 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, West Virginia and Wyoming
- Medical device recall Triglycerides Reagent (TG 2 x 300) It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if… Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report48 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, 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, West Virginia and Wyoming
- Medical device recall Uric Acid Reagent (URIC 2 X 300) It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if… Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report48 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, 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, West Virginia and Wyoming
- Medical device recall Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300) It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if… Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report48 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, 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, West Virginia and Wyoming
- Medical device recall Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400) It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if… Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report48 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, 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, West Virginia and Wyoming
- Medical device recall Seca 402/403 Baby Scale Cart It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the worst case, detach from the cart completely. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report34 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Hawaii, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008… A patch was released for a critical remote code execution vulnerability in remote desktop services. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report51 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereAlaska, 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, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G Lot numbers and products inadvertently not included in the scope of the previous recall. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia and West Virginia
- Medical device recall Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip Lot numbers and products inadvertently not included in the scope of the previous recall. Class IIFDA’s classMar 11, 2020in FDA’s Enforcement Report30 statesnamed in where it went PublishedMar 11, 2020ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia and West Virginia
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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