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 7, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Norian Drillable Inject The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component… Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Norian Drillable Inject The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component… Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN… ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNew Mexico, Ohio, Texas and West Virginia
- Medical device recall ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL… ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNew Mexico, Ohio, Texas and West Virginia
- Medical device recall ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+… ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNew Mexico, Ohio, Texas and West Virginia
- Medical device recall Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1) Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current… Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportGuamthe one state its words name PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereGuam
- Medical device recall The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine,… The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall JS Series SterilContainer S2 System The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Accu-Chek Connect Diabetes Management App Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the… The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AGC 2000 LP Patella, labeled as AGC Porous Patellar SM The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Missouri, New York and Texas named
- Medical device recall AGC 2000 LP Patella, labeled as AGC Porous Patellar Med The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Missouri, New York and Texas named
- Medical device recall Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water… Due to FDA’s safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use… Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Central Venous Catheter Set Triple Lumen Polyurethane Central venous catheters may not fit over guide wire potentially causing procedure delay. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Central Venous Catheter Tray Triple Lumen Polyurethane Central venous catheters may not fit over guide wire potentially causing procedure delay. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane Central venous catheters may not fit over guide wire potentially causing procedure delay. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Central Venous Tray Triple Lumen Polyurethane Catheter Central venous catheters may not fit over guide wire potentially causing procedure delay. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated Central venous catheters may not fit over guide wire potentially causing procedure delay. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall MRx Defibrillator Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 14, 2018ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy… Cardiovascular Systems, Inc. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereFlorida, Illinois, Michigan, Minnesota, Missouri, New York, South Carolina, Texas and Wisconsin
- Medical device recall Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy… Cardiovascular Systems, Inc. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereFlorida, Illinois, Michigan, Minnesota, Missouri, New York, South Carolina, Texas and Wisconsin
- Medical device recall The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they… The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems… Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AIRO Mobile CT System Risk of unintended motion while the AIRO system is in transport mode. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named
- Medical device recall BrightView X During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BrightView XCT During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or… During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Precedence 6 During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Precedence 16 During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DRILL BIT MINI QUICK CONNECT 1.0MM A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement Report35 statesnamed in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall PC-1000, PC-1000/Laser1000 The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Philips Brilliance 64 computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips Ingenuity Core computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips Ingenuity Core 128 computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips Ingenuity CT computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography… One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Disposable Light Handle Cover Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportMichiganthe one state its words name PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Syngo.plaza systems with SW VB20A When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600 The firm is recalling product that has the potential to not function during use. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601 The firm is recalling product that has the potential to not function during use. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602 The firm is recalling product that has the potential to not function during use. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US The firm is recalling product that has the potential to not function during use. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US The firm is recalling product that has the potential to not function during use. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US The firm is recalling product that has the potential to not function during use. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spacelabs Healthcare Xhibit Telemetry Receiver Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereGeorgia, Michigan, New Jersey and Virginia
- Medical device recall 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter The kit was packaged with the incorrect introducer needle size. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNo 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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