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 VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IsoFlex LAL Support Surface Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Kentucky, New Hampshire, Ohio, Pennsylvania and Texas named
- Medical device recall Makoplasty RIO Standard System Communication-connection error. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PR1000 Pivot Rehab Bed AC powered adjustable bed. Under certain conditions, when pivoting bed to the extreme left there are situations where the wire/cables may become pinched. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report28 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall VITROS Chemistry Products Cl- Slides The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. Class IIIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall PATHFAST Myoglobin II reagent cartridge A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Idaho, Louisiana, Minnesota, New York and Texas
- Medical device recall PATHFAST NTproBNP A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Idaho, Louisiana, Minnesota, New York and Texas
- Medical device recall Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher There is a software issue that can potentially impact sample identification and traceability under specific conditions when using EVOware Add On Software:… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Massachusetts, North Carolina, Ohio, Texas and Virginia named
- Medical device recall sterEOS workstation 3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis Q Interventional Fluoroscopic X-Ray System Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARTIS Pheno Interventional Fluoroscopic X-Ray System Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ddR Formula B X-ray System Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Xper Flex Cardio Physiomonitoring System Released with an incorrect, older firmware version installed. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VITROS Chemistry Products CREA Slides The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and… Class IIIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall 2008T HEMODIALYSIS SYS, WITH CDX In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Michigan, North Carolina and New York named
- Medical device recall 2008T HEMODIALYSIS SYSTEM W/BIBAG In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Michigan, North Carolina and New York named
- Medical device recall Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes The product was mislabeled with the incorrect label. Class IIIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 26, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Connecticut, Massachusetts, Michigan, North Carolina, New Jersey, New York, Rhode Island, Texas, Utah and Washington named
- Medical device recall ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Products are labeled with an incorrect expiration date Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedSep 26, 2018ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall URO-3 Triple Stain (CD44 + p53) with CK20 Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida and New York named
- Medical device recall 4.5 Fr x 40 cm single-lumen PICC Kit The products may contain the incorrect catheter. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Georgia, Massachusetts, Maryland, Maine, Michigan, New York, Pennsylvania, Rhode Island, South Carolina, Virginia and Washington
- Medical device recall 5.5 Fr x 40 cm double-lumen PICC Kit The products may contain the incorrect catheter. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report14 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Georgia, Massachusetts, Maryland, Maine, Michigan, New York, Pennsylvania, Rhode Island, South Carolina, Virginia and Washington
- Medical device recall Contour Plus Link 2.4, Product CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Disposable Insulin Syringe 0.3mL Defect consists of a small crack in the top end of the barrel near the needle. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereFlorida, Tennessee and Virginia
- Medical device recall 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall TEMP SENSE SILICONE 14FR5CC2W The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall P400 PREM U/M 18FR TMPSNS The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall P400 PREM U/M 16FR TMPSNS The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use… Potentially have non-conforming internal threads. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportOhiothe one state its words name PublishedSep 26, 2018ClassClass IIStatusOngoingWhereOhio
- Medical device recall Endoscopic Cleaning Brush, single use There is potential risk of brush detachment during cleaning. Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce up to 0.5 mm of positional inaccuracy to the… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Portable Suction Pump, (a) Style 758010 The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall remel THIOGLYCOLLATE MEDIUM W/O IND Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall remel THIOGLYCOLLATE MEDIUM W/O INDICATOR Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall remel THIOGLYCOLLATE MEDIUM Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Wingspan Stent System Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Missouri and Texas named
- Medical device recall ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Kansas, Kentucky, Louisiana, Michigan, Nebraska and Texas
- Medical device recall fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the… Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner). Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 19, 2018ClassClass IIStatusOngoingWhereNationwide, 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, North Carolina, North Dakota, 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 da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 19, 2018ClassClass IIStatusOngoingWhereNationwide, 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, North Carolina, North Dakota, 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 VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver Class IIFDA’s classSep 19, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for… Class IIFDA’s classSep 19, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 19, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Ohio, Pennsylvania, Texas, Virginia and West Virginia
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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