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 EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Set There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Set There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall 10 cc Luer-Slip Loss of Resistance Syringe There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Set There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Set There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Combined Spinal Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Epidural Catheterization Kit with FlexTip Plus Catheter There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall FlexTip Plus Epidural Catheterization Kit There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall EPIDURAL CATHETERIZATION KIT There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into… Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System The devices may be missing the implant coil. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportMarylandthe one state its words name PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereMaryland
- Medical device recall Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil The devices may be missing the implant coil. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportMarylandthe one state its words name PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereMaryland
- Medical device recall Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil The devices may be missing the implant coil. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportMarylandthe one state its words name PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereMaryland
- Medical device recall Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System The devices may be missing the implant coil. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportMarylandthe one state its words name PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereMaryland
- Medical device recall Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil The devices may be missing the implant coil. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportMarylandthe one state its words name PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereMaryland
- Medical device recall Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil The devices may be missing the implant coil. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportMarylandthe one state its words name PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereMaryland
- Medical device recall VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry… Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2 Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended… Incorrect power of lenses than the expected Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended… Incorrect power of lenses than the expected Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Niti-S Esophageal Stent Misprinted IFUs shipped with esophageal stents Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportIndianathe one state its words name PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereIndiana
- Medical device recall ResMed Stellar, Non-invasive/invasive ventilators Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 12, 2020in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 12, 2020ClassClass IStatusCompletedWhereConnecticut, Florida, Georgia, Illinois, Massachusetts, Montana, Pennsylvania, Tennessee and Virginia
- Medical device recall King Vision Video Adapter Size 1/2 Exhibiting a reversed image. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Giraffe Blue Spot PT LiteTM Phototherapy System There is a potential for some systems built between 2014 and Jan 2018 to have a light output falling below the recommended minimum output. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereWisconsin
- Medical device recall Neodent Tapered Guided Surgery Drill, Article No. 103.436 The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the “4.3+ Tapered Guided Surgery Drill”. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereCalifornia and Pennsylvania
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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