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 6, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset with Needleless Adaptor Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall CMExpress Microbore Set Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall CMExpress Microbore Set Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset w/ Non-Vented Spike Connector Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset with Filter Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset with Filter Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall CMExpress Microbore Sets Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall CMExpress Microbore Sets Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall CMExpress Microbore Sets Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset with Male Luer Connectors Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard set with Female Luer Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset with Filter and Manual Priming Valve Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall Standard BodySet with Needleless Connectors Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall CMExpress Microbore Set Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall CMExpress Needleless Y Site Microbore Set Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset With Female Luer Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2020in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 22, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices The device accessories were not labeled with appropriate latex warning. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product… The DAP meters were found to be outside of tolerance. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 22, 2020ClassClass IIStatusCompletedWhereNationwide, and Florida, Kentucky and Louisiana named
- Medical device recall ACUMED CALLOS INJECT 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall ACUMED CALLOS INJECT 3CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall ACUMED CALLOS INJECT 5CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall ACUMED IMPACT 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall ACUMED IMPACT 5CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT C, 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT C, 3CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT C, 5CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT FLOW, 3CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT FLOW, 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT FLOW, CAN, 5CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT FLOW, OUS, 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callos is… Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall CRANIOSCULPT, FLOW 5CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall EXACTECH OSSILIX FIL (MX), 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall EXACTECH OSSILIX FIL (MX), 5CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall EXACTECH OSSILIX FORM (MX), 10CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall EXACTECH OSSILIX FORM (MX), 5CC Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall MEDTRONIC BONE VOID FILLER, LARGE Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall MEDTRONIC BONE VOID FILLER, SMALL Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin named
- Medical device recall OSTEOVATION EX, 3CC, IMPACT FORMULA Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Class IIFDA’s classJul 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Missouri, Mississippi, Ohio, Oklahoma, Oregon, Tennessee, Texas and Wisconsin 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.”
Your shortlist0 of 4
Add one more to compare.