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 ROTEM ex-tem Prolonged clotting times Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereIllinois, Michigan and Wisconsin
- Medical device recall ROTEM ex-tem Canada Prolonged clotting times Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereIllinois, Michigan and Wisconsin
- Medical device recall ROTEM ex-tem Rest of the world Prolonged clotting times Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereIllinois, Michigan and Wisconsin
- Medical device recall HeartStart MRx Monitor/Defibrillator Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these… Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named
- Medical device recall This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for… Class IIIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Micra MC1VR01, Single chamber transcatheter pacing system Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the… Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medtronic Micra MC1VR01 Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the… Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB… Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Indiana, Kentucky, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall Philips 5-Lead Set, Disposable, Bedside, AAMI The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, North Dakota, New York, Ohio, South Carolina, Texas and Utah named
- Medical device recall CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM possibility of the sterility batch being insufficiently sterilized Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM possibility of the sterility batch being insufficiently sterilized Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip… The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media. Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Illinois, Indiana, New York, South Carolina and Texas
- Medical device recall XP- CR Tibial Tray- Interlok 59mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-CR Tibial Tray - Interlok 63mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-CR Tibial Tray - Interlok 65mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-CR Tibial Tray - Interlok 67mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-CR Tibial Tray - Interlok 69mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-CR Tibial Tray - Interlok 71mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-CR Tibial Tray - Interlok 73mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-CR Tibial Tray - Interlok 75mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-CR Tibial Tray - Interlok 79 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-CR Tibial Tray - Interlok 83 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-CR Tibial Tray - Interlok 87 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-CR Tibial Tray - Interlok 91 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-CR Tibial Tray - Porous Plasma 91 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-XP Tibial Tray - Interlok 91mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-XP Tibial Tray - Interlok 87 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-XP Tibial Tray - Interlok 83 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-XP Tibial Tray - Interlok 79 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-XP Tibial Tray - Interlok 75 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-XP Tibial Tray - Interlok 73 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-XP Tibial Tray - Interlok 71 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-XP Tibial Tray - Interlok 69 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-XP Tibial Tray - Interlok 67 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-XP Tibial Tray - Interlok 65 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-XP Tibial Tray - Interlok 63 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall XP-XP Tibial Tray - Interlok 59 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Vanguard XP Tibial Tray 63 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Vanguard XP Tibial Tray 65 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Vanguard XP Tibial Tray 67 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Vanguard XP Tibial Tray 69 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Vanguard XP Tibial Tray 71 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Vanguard XP Tibial Tray 73 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Vanguard XP Tibial Tray 75 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Vanguard XP Tibial Tray 79 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Vanguard XP Tibial Tray 83 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Vanguard XP Tibial Tray 87 mm The locking bar not fully engaging Class IIFDA’s classSep 18, 2019in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT The affected products were inadvertently packaged with an incorrect screw component. Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2019ClassClass IIStatusCompletedWhereNo state 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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