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 5, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall ADVIA Centaur CKMB Calibrator A potential bias was identified with certain kits compared to the internal standards. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur CKMB Calibrator 2-pack Japan A potential bias was identified with certain kits compared to the internal standards. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur CKMB Master Curve Material A potential bias was identified with certain kits compared to the internal standards. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica IM CKMB Calibrator A potential bias was identified with certain kits compared to the internal standards. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica IM CKMB Master Curve Material A potential bias was identified with certain kits compared to the internal standards. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AS-OBGYN Information System version 7.824.x Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be… Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall McKesson Insulin Syringe 0.3mL 31GX5/16 Small hole at the end of the syringe is impeding suction of liquid. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer Some of the Disposable Smooth Interior Tubing may pull apart when stretched. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNorth Carolina, Ohio and Pennsylvania
- Medical device recall CryoPatch SG Pulmonary Hemi-Artery, 1 graft The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Affixus Hip Fracture Nail 125 9 mm x 180 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 9 mm x 260 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 9 mm x 300 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 9 mm x 320 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 9 mm x 340 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 9 mm x 360 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 9 mm x 380 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 9 mm x 440 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 9 mm x 460 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail 125 11mm x 180mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 11 mm x 340 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 11 mm x 360 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 11 mm x 380 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 11 mm x 420 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 11 mm x 440 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 11 mm x 460 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 13 mm x 180 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 13 mm x 260 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 13 mm x 280 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 13 mm x 300 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 13 mm x 360 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 13 mm x 400 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 125 13 mm x 440 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 125 9 mm x 260 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 125 9 mm x 300 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 125 9 mm x 320 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 125 9 mm x 440 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 125 9 mm x 460 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 125 11 mm x 260 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 125 11 mm x 320 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail - Left 125 11mm x 340mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 125 11 mm x 360 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 125 13 mm x 260 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 125 13 mm x 340 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Left 125 13 mm x 360 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 130 9 mm x 320 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail 130 11 mm x 180 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 130 11 mm x 320 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Affixus Hip Fracture Nail Right 130 11 mm x 340 mm There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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