Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X… The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 22MM X 45MM | 75CM L,… The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L,… The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM… The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM,… The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Vascular Solutions Venture Rx Catheter, 6F, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue… The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereFlorida, Nevada, Oklahoma, South Carolina and Texas
- Medical device recall VITROS Chemistry Products Cl- Slides The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Class IIIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall VITROS Chemistry Products Cl- Slides The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Class IIIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip A small number of devices in this lot may have a melted cap and a hole formed through the packaging. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Iowa, Idaho, Illinois, Massachusetts, Michigan, Minnesota, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Utah and Washington named
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 280 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 300 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 320 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 360 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 380 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 420 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 280 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 300 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 320 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 340 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 360 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 380 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 400 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 420 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 440 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 460 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 180 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 260 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 280 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 300 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 320 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 360 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 380 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 400 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 420 mm,Item Number: 814313420 The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 440 mm The set screw is not able to advance or reverse from the original position in the nail. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report42 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
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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