Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall 3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and… In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break… Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois and New York named
- Medical device recall Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac… The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the… Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereTexas
- Medical device recall ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform,… There is a potential for an uncontrolled extension of iViewGT / XVI detector arms. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost Release 3 (Stitching Patient Support) 712025 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BuckyDiagnost Ceiling System (Stitching Patient Support) 704031 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CombiDiagnost R90 (Stitching Patient Support) 709030 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost 4.1 (Stitching Patient Support) 712225 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost Release 3 (Stitching Patient Support) 712025 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost Single Detector (Stitching Patient Support) 712020 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost Upgrades (Stitching Patient Support) 712083 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EasyDiagnost Eleva DRF (Stitching Patient Support) 706032 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050 The hook does not securely hold the footplate in the vertical position. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD BBL GC-Lect Agar A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement Report29 statesnamed in where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Idaho, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Mississippi, Montana, North Carolina, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin
- Medical device recall GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680 GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Wisconsin, West Virginia and Wyoming named
- Medical device recall GE Healthcare Optima CT660 GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Wisconsin, West Virginia and Wyoming named
- Medical device recall GE Healthcare Optima CT540 GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Wisconsin, West Virginia and Wyoming named
- Medical device recall GE Healthcare Optima CT660 GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Wisconsin, West Virginia and Wyoming named
- Medical device recall bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software… Missing desiccant. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Connecting Bolt Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New York, Ohio, South Carolina, Texas, Utah and Wisconsin
- Medical device recall Persona Partial Knee System Spacer Block Alignment Tower The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues… Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ulnar Osteotomy Compression Plate, Short Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereTexas
- Medical device recall CoLink(TM) Lapidus Plate XP, +2 mm, Right CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CoLink(TM) Lapidus Plate XP, +2 mm, Left CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow) Packages labeled as containing 110mm rods may contain 100mm rods. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportOhiothe one state its words name PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Vertebral Motion Analyzer (VMA) Version 2.3.252 Ortho Kinematics Inc. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Incomplete seal on the Tyvek lid may compromise the sterility of the device Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportKentuckythe one state its words name PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereKentucky
- Medical device recall O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Higher levels of nitrous oxide delivered than specification Class IIFDA’s classAug 29, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereAlaska, California and Florida
- Medical device recall Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Illinois, Massachusetts, Missouri, New Hampshire, New Mexico, New York, Texas, Utah, Virginia and Wisconsin
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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