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 PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers Merit Medical Systems, Inc. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740) Device may provide inaccurate measurements. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The kit may contain an incorrect catheter component. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereArizona, California, Georgia, Massachusetts, Missouri, New York and Virginia
- Medical device recall Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral… Needle supplier indicated the presence of loose polypropylene foreign matter above release specification. 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 Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system… A software issue causes PET reconstructions to fail intermittently. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereCalifornia, Illinois, New York, Ohio and Pennsylvania
- Medical device recall Vado Steerable Sheath 8.8F Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the… Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereDistrict of Columbia, Florida, Georgia, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, South Carolina and Virginia
- Medical device recall Vado Bi-Directional Steerable Sheath 8.8F Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the… Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereDistrict of Columbia, Florida, Georgia, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, South Carolina and Virginia
- Medical device recall BARD(R) CRITICORE(R) MONITOR BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder… 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 Medtronic ANGLED DRILL Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereMinnesota and North Carolina
- Medical device recall Perifix Continuous Epidural Anesthesia Tray B. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perifix Single Dose Epidural Anesthesia Tray B. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pencan Spinal Needle Tray B. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perifix Epidural AnesthesiaTray B. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perifix FX Epidural Anesthesia Tray B. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PENCAN Spinal Anesthesia Tray B. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spinal & Epidural Anesthesia Tray B. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Customer Epidural Anesthesia Tray B. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pain Management Tray B. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Contiplex Nerve Block Tray B. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a… Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization. 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 EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930 The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Missouri, Mississippi, South Dakota, Tennessee, Texas and Wisconsin
- Medical device recall Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2 Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall AVID Medical QA Pack AV10654-10 The swab stick collection device provided in a convenience kit expires prior to the kit expiration date. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kansas, Kentucky, Massachusetts, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, Texas and Virginia
- Medical device recall NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The… The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10… Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when… Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedFeb 21, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 Incorrect device in the package. 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 CORAIL HIGH OFFSET STEM Collarless SIZE 14 Incorrect device in the package. 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 Hologic Panther(R) Fusion(TM) The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator. 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 Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon… Potential for the Persona Partial Knee Impactor Pad to fracture. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, New Jersey, New Mexico, Pennsylvania, South Carolina, Texas, Washington and Wisconsin named
- Medical device recall Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw… The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended… Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended… Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Total Knee Replacement Implant kit mislabeled Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereCalifornia and Texas
- Medical device recall ARROW PICC powered by ARROW VPS Stylet Finished good kits may contain incorrect components. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC) Finished good kits may contain incorrect components. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool Vix Bit may fracture during use. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medical device recall 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereGeorgia, Pennsylvania, Texas and Utah
- Medical device recall Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended… Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report44 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, 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, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE The firm information that the product was reporting false positive results Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona and Mississippi
- Medical device recall Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular… Contamination with Methylbacterium thiocyanatum Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants Abutments are unable to accept the final abutment screw Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts, North Dakota and New Jersey named
- Medical device recall BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to… Cut resistant surgical glove liners lack sterility assurance. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report29 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereArizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and West Virginia
- Medical device recall A.T.S. 4000TS Tourniquet Systems, Personalized Pressure Updated on-device label and 3 pages of an updated Operator/Service Manual. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 A.T.S. 2200TS Tourniquet Systems, Personalized Pressure Updated on-device label and 3 pages of an updated Operator/Service Manual. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Artis oneFloor-mounted system for uncompromised imaging The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Indiana, Louisiana, Michigan, Missouri, North Carolina, New York, Pennsylvania, Texas and Washington
- Medical device recall Video Cystoscope models ECY-1570 and ECY-1570K The video cytoscopes lack 510(k) premarket notification clearance. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereCalifornia, Guam, Illinois, Maryland, Michigan, North Dakota, New Hampshire, New York and South Dakota
- Medical device recall Purely Yours Breast Pump Two specific lots was incorrectly manufactured containing a UK power adapter. Class IIIFDA’s classFeb 21, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIIStatusOngoingWhereCalifornia, District of Columbia, Delaware, Florida, Georgia, Illinois, Maryland, North Carolina, New Jersey, Ohio, Texas, Utah, Virginia and Washington
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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