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 7, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Lumenis M22 System Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Georgia, Kentucky, Louisiana, Massachusetts, Minnesota, New Jersey, New York, Rhode Island and South Carolina
- Medical device recall ADVIA Chemistry Triglyceride_2, concentrated Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity… Class IIFDA’s classMay 25, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Kansas, Michigan, Minnesota, North Carolina, New Mexico, New York, Oklahoma, Oregon, Tennessee, Texas, Utah and Washington
- Medical device recall AB Sciex Triple Quad 4500MD LC/MS/MS System Under certain conditions, mass spectrometers may report incorrect quantitative results. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall Visualase Cooled Laser Applicator System (VCLAS) Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical… A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401 A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801 A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm… A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm… A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN… A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter,… A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated… A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length… A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap… A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550… A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the… A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the… A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the… A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall LenSx Laser System Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation,… Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Diamedix Is-CMV IgG Test Kit Product contained an incorrect substrate. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Oregon, Puerto Rico, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall 1) 24 G x 0.75 in The device may have a defect in the catheter. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical… The product has potential to leak beyond their design specification. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 25, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall 23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical… The product has potential to leak beyond their design specification. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 25, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye… The product has potential to leak beyond their design specification. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 25, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Orapharma (Onpharma) Onset Mixing Pen It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use. Class IIFDA’s classMay 25, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 25, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Battery Pack Used with the Capnostream”20 and Capnostream”20p Patient Monitor, Battery Packs Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream”20 and Capnostream”20p Patient Monitor… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMay 18, 2016ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4 The SUV values that are being calculated in the PET/CT fusion tool are incorrect. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME:… The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide. Class IIIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Missouri and West Virginia named
- Medical device recall Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating… The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the… Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report47 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative… Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of… Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Michigan, Montana, North Carolina, New Jersey, New York, Pennsylvania, Texas and Virginia
- Medical device recall Given Imaging Bravo¿ pH capsule delivery device, 5-pack Potential of an allergic reaction in a patient with nickel sensitivity. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack Potential of an allergic reaction in a patient with nickel sensitivity. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and… Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report44 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic… Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may… Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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 Distal Femoral Replacement (patient specific, custom made orthopedic implant device) Incorrect component used to manufacture distal femoral replacement. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportOhiothe one state its words name PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Hamilton G5 with software version between v2.41, v2.42, v2.50 After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation… Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Mallinckrodt Evac Tracheal Tubes Device packaging may not be sealed. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportKentuckythe one state its words name PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereKentucky
- Medical device recall Launcher Guiding Catheter Device packaging may not be sealed. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportKentuckythe one state its words name PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereKentucky
- Medical device recall GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO Instructions for use booklet may puncture the outer Tyvek lid. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO Instructions for use booklet may puncture the outer Tyvek lid. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO Instructions for use booklet may puncture the outer Tyvek lid. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO Instructions for use booklet may puncture the outer Tyvek lid. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO Instructions for use booklet may puncture the outer Tyvek lid. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ellipse ICD (Implantable Cardioverter Defibrillator) St. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Georgia, New Jersey and South Carolina named
- Medical device recall Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereArkansas, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Maryland, Michigan, Puerto Rico, Texas and Wisconsin
- Medical device recall CinchLock SS Knotless Anchor with Inserter Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal… Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 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.”
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