Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall V-TEK”, IVP step drill 2-3.4x124mm, 16mm stop, contra-angle An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 3.5x90mm, round shaft An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall V-TEK”, IVP step drill 2-3.4x124mm, 16mm stop, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall V-TEK”, IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall V-TEK”, IVP step drill 2.5-3.9x124mm, 16mm stop, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 4x90mm, round shaft An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, 3.2x145mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, contra-angle, 1.5x85mm An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CBS 7.5 tap, cannulated, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MaxiCan 4.5 countersink, cannulated, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CBS micro, countersink, cannulated, round-shaft An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CBS high, countersink, cannulated, round-shaft An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CBS 4.5 countersink, cannulated, 18mm stop, round-shaft An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CBS 4.0 countersink, cannulated, 15mm stop, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CBS 4.0 countersink, cannulated, 30mm stop, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CBS micro, countersink, cannulated, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CBS high, countersink, cannulated, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall V-TEK”, standard-countersink, cannulated, round shaft An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall V-TEK”, standard-countersink, cannulated, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall V-TEK”, micro-countersink, round shaft An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall V-TEK”, Micro-countersink, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall V-TEK”, standard-countersink, cannulated, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall V-TEK”, Micro-countersink, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill for 2.7mm screw, 23mm stop, 2x103mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill for 2.7mm screw, 2x100mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill for 2.7mm screw, 2x120mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill for 3.5mm screw, 2.5x120mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, 2.7x125mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 4x120mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 4x150mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 2x95mm, round shaft An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 2.5x95mm, round shaft An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 2.5x95mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 2x95mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 2.8x120mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 3x90mm, round shaft An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 3x90mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 3.5x90mm, round shaft An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, cannulated, 4x90mm, round shaft An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, 3.2x145mm, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Drill, contra-angle, 1.5x85mm An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CBS micro, countersink, cannulated, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall CBS high, countersink, cannulated, AO An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Curved Intraluminal Staplers, 21 mm diameter The staplers may have an insufficient firing stroke to break the washer and completely form staples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusCompletedWhereNationwide
- Medical device recall Curved Intraluminal Staplers, 25 mm diameter The staplers may have an insufficient firing stroke to break the washer and completely form staples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusCompletedWhereNationwide
- Medical device recall Curved Intraluminal Staplers, 29 mm diameter The staplers may have an insufficient firing stroke to break the washer and completely form staples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusCompletedWhereNationwide
- Medical device recall Curved Intraluminal Staplers, 33 mm diameter The staplers may have an insufficient firing stroke to break the washer and completely form staples. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusCompletedWhereNationwide
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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