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 #2 Bipolar stem implant (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Stem Implant non-coated, Size 2 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall #3 Bipolar stem implant (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Stem Implant non-coated, Size 3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall #4 Bipolar stem implant (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead Recon Stem Implant non-coated, Size 4 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall radial head implant #2 (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall radial head implant #3 (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall radial head implant #4 (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall radial stem implant #1 (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead, Radial Implant 6 mm Collar, Size 1 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall radial stem implant #2 (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall radial stem implant #2 (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall radial stem implant #3 (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead, Radial Implant 6 mm Collar, Size 3 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall radial stem implant #4 (Sterile Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall rHead, Radial Implant 6 mm Collar, Size 4 Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expiration date (11/2017). Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Waterpik Sonic-Fusion Professional Charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 15, 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, 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 Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that… Potential polymer material degradation. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nevada, New York, Ohio, Oregon, Tennessee, Texas, Utah and Washington named
- Medical device recall iTOVi Tracker/Scanner The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD… Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may cause the cart s video pole to fail. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement Report47 statesnamed in where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and… The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003 Potential for unintentional movement of the support surface of the bed from tilted position to horizontal position or any position in between. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Slit Knife 2.6mm 45degree Bevel Up Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton. Class IIFDA’s classAug 15, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 15, 2018ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Maryland, Minnesota, New Jersey, Ohio and Pennsylvania
- Medical device recall SOMATOM Emotion 6 (Model 10165888) A potential risk of unnecessary radiation exposure due to a software issue Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Emotion 16 A potential risk of unnecessary radiation exposure due to a software issue Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Perspective (Model 10495568) A potential risk of unnecessary radiation exposure due to a software issue Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Perspective 16 (Model 10891666) A potential risk of unnecessary radiation exposure due to a software issue Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Scope ( A potential risk of unnecessary radiation exposure due to a software issue Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Scope Power (Model 10967888) A potential risk of unnecessary radiation exposure due to a software issue Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Spirit(Model 10045692 ) A potential risk of unnecessary radiation exposure due to a software issue Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington
- Medical device recall 1) Vascular Dilator, Sterile EO The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington
- Medical device recall 1) Drainer Centesis Catheter, Sterile EO The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington
- Medical device recall 1) TVS LPA, Sterile EO The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington
- Medical device recall Elite HV Introducer The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington
- Medical device recall Centeze Centesis Catheter The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington
- Medical device recall TVS LPA, Catalog #: DIL-059-00 The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington
- Medical device recall Tearaway Introducers The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington
- Medical device recall Merge Unity software, formerly known as DR Systems Unity PACS software The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maine, Ohio, Oregon, Tennessee, Texas, Washington and West Virginia named
- Medical device recall Custom Made Implant System with Minimum Invasive Grower (MIG) component From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related… Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereFlorida, Kansas and New York
- Medical device recall Nicolet¿ Ambulatory EEG Potential to be able to import an ambulatory exam for a patient for which the exam was not started. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report25 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Massachusetts, Maine, Michigan, Missouri, North Carolina, North Dakota, New Jersey, Nevada, New York, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall FlowGate2 Balloon Guide Catheter, UPN 90485 There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall XLTEK EMU40EX EEG Headbox Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report34 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a A review of complaints identified a trend for drills breaking. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report36 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall VNS Therapy Programming System Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer. Class IIFDA’s classAug 8, 2018in FDA’s Enforcement Report16 statesnamed in where it went PublishedAug 8, 2018ClassClass IIStatusTerminatedWhereArizona, California, Georgia, Iowa, Illinois, Indiana, Missouri, Montana, North Carolina, New York, Pennsylvania, South Dakota, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Contains a gel-like contaminant that may affect product performance. Class IIIFDA’s classAug 8, 2018in FDA’s Enforcement Report20 statesnamed in where it went PublishedAug 8, 2018ClassClass IIIStatusTerminatedWhereArizona, California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas 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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