Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall AFX Endovascular AAA System Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AFX2 Endovascular AAA System Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Human Lambda Free SPAPlus Kit Calibration curve activity has increased over time in the kit lots listed. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereArizona, California, Georgia, Hawaii, Idaho, Massachusetts, New York, Oklahoma, Pennsylvania, Texas and Utah
- Medical device recall Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative,… The Great Basin Staph ID/R Panel is being recalled because the S. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Carestream Touch Prime Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in… Class IIFDA’s classJan 25, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereGeorgia, Iowa, New York, Ohio, South Carolina and Texas
- Medical device recall Freelite Human Lambda Free Kit for use on SPAPLUS A change in the calibration curve causing an increase in false prozone flags. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts… Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System). Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Digital RID Plate Reader and Software If a control ring is marked after reading, the software will not flag results that are out of the specified QC range. Class IIFDA’s classJan 25, 2017in FDA’s Enforcement Report11 statesnamed in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Iowa, Illinois, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New York and Utah
- Medical device recall APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with… Customer complaints received for the presence of leaks Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to… The fuse blows during initial power up or after a period of time. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, Massachusetts, Mississippi, North Carolina, New Jersey, New York, Texas, Virginia and Washington
- Medical device recall SCREW 02.7-12MM LOCKING Dimensional non-conformity of the thread on the screw head. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall NEO SCREW 02.7-14MM LOCKING Dimensional non-conformity of the thread on the screw head. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall NEOVIEW(R) SCREWS SET Dimensional non-conformity of the thread on the screw head. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall VOCO Futurabond M+ adhesive, RF 1515 Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal Adhesive. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and Florida, Iowa, New Hampshire, Pennsylvania, South Carolina and Texas named
- Medical device recall Oxford Fixed Lateral Bearing Size F Right Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile Drills cannot be inserted into handpiece due to tolerance specification not met Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile Drills cannot be inserted into handpiece due to tolerance specification not met Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Femoral and Tibial Cutting Block Adapter Base Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereDistrict of Columbia, New York, Oklahoma and Wisconsin
- Medical device recall Tiger Screw Sterilization Tray Base Assembly Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GoDirect Screw-Retaining Top Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereWashington
- Medical device recall Amplia MRI” CRT -D SureScan”, Amplia MRI” Quad CRT -D SureScan”, Claria MRI” CRT -D SureScan”, Claria MRI”… During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Reprocessed Ablation Catheter Cable A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement Report35 statesnamed in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Reprocessed Electrophysiology Catheter Cables A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement Report35 statesnamed in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall EVOTECH Endoscope Cleaner and Reprocessor System 208V Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device… Absent tantalum market pin. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall SURESTEP Tray, BARDEX I.C The product contained a latex catheter instead of a silicone catheter. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement Report23 statesnamed in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Nebraska, New Jersey, New Mexico, Nevada, New York, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated… Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated… Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film… GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement Report50 statesnamed in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereAlaska, 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, 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
- Medical device recall OEC MiniView 6800 GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement Report50 statesnamed in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereAlaska, 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, 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
- Medical device recall The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the… GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement Report50 statesnamed in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereAlaska, 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, 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
- Medical device recall Alcon Monarch III The intraocular lens could become lodged within the cartridge Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number… Siemens is conducting this recall for the IMMULITE¿ 2000/IMMULITE¿ 2000 XPi Intact PTH (Intact Parathyroid Hormone) (iPTH) assay kit lot 320. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 133” 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext ICU Medical Inc. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall StatLock¿ PICC Plus Crescent Foam Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization Devices because some single unit pouches have been released… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StatLock¿ CV Plus w/Pigtail Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization Devices because some single unit pouches have been released… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove… According to firm ( Bausch & Lomb, Inc. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medline E-Z Lubricating Jelly Product was not sterilized. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Michigan, Pennsylvania, Texas and Wisconsin named
- Medical device recall MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Hawaii, Illinois, Massachusetts, Maryland, New Jersey, Ohio, Oregon and Texas named
- Medical device recall SafeStep¿ Huber Needle Set with Y-Injection Site Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without… Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Hawaii, Illinois, Massachusetts, Maryland, New Jersey, Ohio, Oregon and Texas named
- Medical device recall Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software… Cross profile for Varian 60 degree wedge shows “horns.” Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, District of Columbia, North Dakota, Nebraska, New York, Oregon, Pennsylvania, Rhode Island, South Carolina and Texas named
- Medical device recall Tego Connector ICU Medical Inc. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device… The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulting in a mislabeling of final IV bag preparations. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring… Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereFlorida, New Jersey, Oregon and Tennessee
- Medical device recall ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are… Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are… Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are… Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass 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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