Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall UltraStream Peel Away Kit UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High Disposable Patient Circuit that allows water to leak into the center gas lumen Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High Disposable Patient Circuit that allows water to leak into the center gas lumen Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High Disposable Patient Circuit that allows water to leak into the center gas lumen Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High Disposable Patient Circuit that allows water to leak into the center gas lumen Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low Disposable Patient Circuit that allows water to leak into the center gas lumen Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low Disposable Patient Circuit that allows water to leak into the center gas lumen Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low Disposable Patient Circuit that allows water to leak into the center gas lumen Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low Water may leak into the center gas lumen of the Patient Circuit Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Guam, Iowa, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas and Washington named
- Medical device recall Dako Autostainer Link 48 with software version Dako Link 4.0.3 Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has determined that an upgrade to this version of the software may… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and California and Delaware named
- Medical device recall Brilliance CT System 6/10/16/16P/40 configuration The system has a gap that can appear between the upper and lower tilt stand covers. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereArizona, Colorado, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, Texas, Vermont and Wisconsin
- Medical device recall C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100… Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD BBL Vancomycin Screen Agar These lots of Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 24, 2014ClassClass 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, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Products were held at improper storage temperature Class IIFDA’s classSep 24, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereLouisiana, Oklahoma and Texas
- Medical device recall BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Products were held at improper storage temperature Class IIFDA’s classSep 24, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereLouisiana, Oklahoma and Texas
- Medical device recall BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Products were held at improper storage temperature Class IIFDA’s classSep 24, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereLouisiana, Oklahoma and Texas
- Medical device recall BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Products were held at improper storage temperature Class IIFDA’s classSep 24, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereLouisiana, Oklahoma and Texas
- Medical device recall BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Products were held at improper storage temperature Class IIFDA’s classSep 24, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereLouisiana, Oklahoma and Texas
- Medical device recall BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Products were held at improper storage temperature Class IIFDA’s classSep 24, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereLouisiana, Oklahoma and Texas
- Medical device recall SUN DASH RADIUS 252 PN 8000809705 The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process). Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volcano TrakBack II Disposable Pullback Device Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software… Potential issues with the ProVue driver have been identified which may cause data to be misassociated with patient results under a given set of circumstances. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Indiana, Louisiana, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Amerigel Wound Dressing Maximum Strength Not approved labeling claims (antimicrobial and autolytic debridement) Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, 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, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Amerigel Hydrogel Saturated Gauze Dressing Not approved labeling claims (antimicrobial and autolytic debridement) Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, 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, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Amerigel Post-Op Surgical Kits Not approved labeling claims (antimicrobial and autolytic debridement) Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, 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, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Amerigel Daily Dressing Advanced 3-in-1 Hydrogel Not approved labeling claims (antimicrobial and autolytic debridement) Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, 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, US Virgin Islands, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister) suction canister lids may have occluded ports. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens… The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall JBAIDS Instrument System Software version 3.5.0.72 BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version software may have been installed. Class IIIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 24, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Guam named
- Medical device recall Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim ‘n Trim,… Marketing without marketing clearance or approval. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas, Utah and Virginia
- Medical device recall Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim ‘n Trim,… Marketing without marketing clearance or approval. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas, Utah and Virginia
- Medical device recall Photonica Light Modulator Marketing without marketing clearance or approval. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas, Utah and Virginia
- Medical device recall Bard DuaLok Breast Lesion Localization Wire Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a… It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Indiana, Maine, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Stago IVD, Liquid Anti-Xa Diagnostica Stago Inc. Class IIIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Coulter DxH Diluent Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in… ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke during use. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VERO Linear Accelerator System Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereFlorida, New York and Texas
- Medical device recall 4D Integrated Treatment Console Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian’s Bar Code Conical Verification… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportMissourithe one state its words name PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Zenith Slide W-I-D-E Long Term Care Bed The bed head deck may fail to elevate as expected during normal operation. Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System. Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement Report18 statesnamed in where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereArkansas, California, Connecticut, Delaware, Iowa, Idaho, Illinois, Indiana, Maryland, Michigan, Missouri, Nebraska, New York, Ohio, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Sterility of device is not assured Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Sterility of device is not assured Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft Sterility of device is not assured Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur Immunoassay System The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are… Class IIFDA’s classSep 24, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 24, 2014ClassClass 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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