Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Dynasty Liners Revision rate trends from within the MicroPort Orthopedics Inc. Class IIIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Procotyl (Rim- Lock) Liners Revision rate trends from within the MicroPort Orthopedics Inc. Class IIIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Lineage Shell Revision rate trends from within the MicroPort Orthopedics Inc. Class IIIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Conserve Shells Revision rate trends from within the MicroPort Orthopedics Inc. Class IIIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Conserve Cups Revision rate trends from within the MicroPort Orthopedics Inc. Class IIIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023,… Revision rate trends from within the MicroPort Orthopedics Inc. Class IIIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall FMsealer Open Shears Domain Surgical, Inc. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures Positive results from non-routine sterility testing commissioned by B. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia and Illinois named
- Medical device recall Philips Healthcare System X-ray Tomography Computed It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential… Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Washington and Wyoming named
- Medical device recall Philips Healthcare System X-ray Tomography Computed It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential… Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Washington and Wyoming named
- Medical device recall Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31 It was reported by a customer that RadSuite images are not appearing as readable images. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Indiana, Michigan, Missouri, New York, Pennsylvania, Tennessee and Wisconsin named
- Medical device recall Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger… Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Greatbatch Stiffer Coaxial Micro-Introducer Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer… Class IIFDA’s classNov 30, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNew York and Texas
- Medical device recall DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereCalifornia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Missouri, North Carolina, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia
- Medical device recall DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereCalifornia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Missouri, North Carolina, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia
- Medical device recall DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereCalifornia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Missouri, North Carolina, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia
- Medical device recall DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereCalifornia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Missouri, North Carolina, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia
- Medical device recall DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereCalifornia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Missouri, North Carolina, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia
- Medical device recall DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereCalifornia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Missouri, North Carolina, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia
- Medical device recall DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereCalifornia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Missouri, North Carolina, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia
- Medical device recall Fluid Management Set Merit Medical Systems, Inc. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, Utah and Virginia named
- Medical device recall Manifold Kit Merit Medical Systems, Inc. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, Utah and Virginia named
- Medical device recall Waste Management Kit Merit Medical Systems, Inc. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, Utah and Virginia named
- Medical device recall Pressure Monitoring Kit (MeriTrans”) Merit Medical Systems, Inc. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, Utah and Virginia named
- Medical device recall Procedure Kit Merit Medical Systems, Inc. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, Utah and Virginia named
- Medical device recall Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source),… Pentax is initiating the product correction of several model numbers of Pentax’s Colonoscope that were shipped between the clearance date of April 2014 and… Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.0 mm Reaming Rod/950 mm, Sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.0 mm Guide Rod/950 mm with Smooth Tip, sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Extraction Hook - Sterile for TI Cannulated Nails The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile The peel pouches for the affected reaming rods and extraction hooks are delaminating. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent… DiaSorin is issuing an urgent medical device correction for the LIAISON¿ Estradiol II Gen assay. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Idaho, New Jersey, Nevada, New York and Pennsylvania named
- Medical device recall Pathfast D-Dimer, Reference number: PF1051-KUS Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereAlabama, Florida, Idaho and Massachusetts
- Medical device recall AQUIOS Lyse Reagent Kit Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL… Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Custom Fluid Management Set, Sterile, EO Merit Medical Systems, Inc. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACTIS Flex Reamers SZ 0/1 DePuy Orthopaedics, Inc. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereCalifornia, Kentucky, Louisiana, Maryland, Maine, North Carolina, New Hampshire, New York, Texas, Virginia and Washington
- Medical device recall PeroxiClear Peroxide Solution Product was found to contain excess residual levels of hydrogen peroxide. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product… Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista¿ CHEM 1 CAL lots 5GM081 and 5GM082. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent… Class IIFDA’s classNov 30, 2016in FDA’s Enforcement Report37 statesnamed in where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall The Hemotherm 400CE 115v, containing power board p/n 39945 The device may not maintain water flow or temperature control. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement Report10 statesnamed in where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Massachusetts, Minnesota, North Carolina, New Jersey, Ohio, Pennsylvania and South Carolina
- Medical device recall SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices Breach in sterile barrier compromising product sterility Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an… Non-conforming material used. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant¿ Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test .Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant¿ Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
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.”
Your shortlist0 of 4
Add one more to compare.