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 Laseredge 1.1mm Arrow Knife Angled Possible dull knife edge Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED Possible dull knife edge Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems… Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Kansas, Michigan, Minnesota, North Carolina, North Dakota, New York, Ohio, South Carolina, Texas and Wisconsin named
- Medical device recall EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903270, 14.5F, Straight… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913230, 16F, Straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913270, 16F, Straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393190, 14.5F, Straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393270, 14.5F, Straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393420, 14.5F, Straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve, 19cm length, BARD,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve, 19cm length, BARD,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve, 28cm length, BARD,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397270, 14.5F, straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397310, 14.5F, straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397350, 14.5F, straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight,… The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 4, 2019ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen… An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medical device recall Phadia” 1000 code 7-102 Liquid Sensor Error Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall EyeBOX Model OCL 02 A review of the user manual revealed that two precaution statements were missing. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereMaryland and New York
- Medical device recall SOMATOM go.Now The injector holder could potentially fall off together with the injector and the storage box. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas and Wisconsin named
- Medical device recall SOMATOM go.Up The injector holder could potentially fall off together with the injector and the storage box. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas and Wisconsin named
- Medical device recall SOMATOM go.Up The injector holder could potentially fall off together with the injector and the storage box. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas and Wisconsin named
- Medical device recall SOMATOM go.All The injector holder could potentially fall off together with the injector and the storage box. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas and Wisconsin named
- Medical device recall SOMATOM go.All The injector holder could potentially fall off together with the injector and the storage box. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas and Wisconsin named
- Medical device recall SOMATOM go.Top The injector holder could potentially fall off together with the injector and the storage box. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas and Wisconsin named
- Medical device recall SOMATOM go.Top The injector holder could potentially fall off together with the injector and the storage box. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas and Wisconsin named
- Medical device recall Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 4, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth… Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 4, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Skull Anchor Bolts Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedSep 4, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monaco Radiation Treatment Planning System (RTP) System Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect… Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereIndiana and Ohio
- Medical device recall DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva Salivary Progesterone assay may observe a higher percentage of samples with low results. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Product Pouches may not be sealed properly and compromise the sterility of the device Class IIFDA’s classSep 4, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereCalifornia and Illinois
- Medical device recall Endotrig ETF Hook Blade The seal integrity of the sterile bag containing the kits may be compromised. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
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.”
Your shortlist0 of 4
Add one more to compare.