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 5, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall SWANSON FINGER JOINT #2 The firm discovered a lack of adequate documentation confirming sterility on certain products. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SWANSON TRAPEZIUM IMPLANT The firm discovered a lack of adequate documentation confirming sterility on certain products. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CPS CALCANEAL PLATE SML 54MM The firm discovered a lack of adequate documentation confirming sterility on certain products. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ARCHITECT HAVAB-G Calibrator Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement Report22 statesnamed in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Oregon, Rhode Island, South Carolina, Tennessee, Texas, Washington and West Virginia
- Medical device recall Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the… Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New York, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm The incorrect outer carton box was used for the product. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereIowa, Michigan and New Jersey
- Medical device recall Emerge Monorail PTCA Dilatation Catheter Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious… Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious… Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall NC Emerge Monorail PTCA Dilatation Catheter Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious… Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Rebel Monorail PtCr Coronary Stent System Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious… Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Atellica CH 930 Analyzer Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement Report35 statesnamed in where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Washington and West Virginia
- Medical device recall PowerPort isp M.R.I Complaints received that products packaged with the incorrect introducer sheath size. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Behind-the-Ear hearing aids GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration… Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall In-the-Ear hearing aids GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration… Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 4Fr x 20cm Single Lumen CT Midline Basic Tray Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray. Class IIFDA’s classDec 4, 2019in FDA’s Enforcement ReportTennesseethe one state its words name PublishedDec 4, 2019ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall Monarch, Aspirating Biopsy Needle Reports of aspirating biopsy needle breakage Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Illinois, Michigan, Minnesota, Mississippi, Ohio, Oklahoma, Pennsylvania and Tennessee named
- Medical device recall SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereGeorgia, Indiana, Missouri, Mississippi, New Jersey, Ohio and Pennsylvania
- Medical device recall EPISTAXIS TRAY Kit Code: MNS10165 Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manufacturer Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereConnecticut and Illinois
- Medical device recall YNHH SCOPE KIT Kit Code: MNS10475 Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manufacturer. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereConnecticut and Illinois
- Medical device recall NOSEBLEED TRAY Kit Code: MNS3885 Various medical device kits contain MAJOR Nasal Decongestant Spray is being recalled by the manufacturer. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereConnecticut and Illinois
- Medical device recall Starburst Talon Semi-Flex Electrosurgical Device The devices are not labelled correctly. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereLouisiana, Massachusetts, Oregon, Virginia and Washington
- Medical device recall Randox Liquid Cardiac Controls Catalogue Number CQ5051 Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Georgia, Indiana, New Jersey, New York, Puerto Rico and West Virginia
- Medical device recall Randox Liquid Cardiac Controls Catalogue Number CQ5052. Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed decrease in recovery for N-Terminal Pro-Brain… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Georgia, Indiana, New Jersey, New York, Puerto Rico and West Virginia
- Medical device recall Randox Liquid Cardiac Controls Catalogue Numbers CQ5053. Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Georgia, Indiana, New Jersey, New York, Puerto Rico and West Virginia
- Medical device recall Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity. Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity. Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a… Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CoolBlue Hyper-Hypothermia System- body hypothermia system Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EZ Glide Aortic Cannula, 24 Fr. Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could… Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2019ClassClass 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular… The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Class IIFDA’s classNov 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedNov 27, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia 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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