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 Medical Positioning Rapid Response HUT table, Powered Medical Examination table Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Medical Positioning Rapid Response HUT table, Powered Medical Examination table Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Medical Positioning Rapid Response HUT table, Powered Medical Examination table Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone… The firm received complaints indicating that the drill guide becomes stuck in the jig. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report12 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Georgia, Iowa, Illinois, Maryland, North Carolina, New York, Pennsylvania and Virginia
- Medical device recall Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization… Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, New York, Ohio and Wisconsin named
- Medical device recall VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereIllinois, Kentucky, Massachusetts, Mississippi, Ohio, Puerto Rico and Texas
- Medical device recall Moore Hip Prosthesis Long Fenestrated Stem 38 mm Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Minnesota, Oregon, Texas and Wisconsin named
- Medical device recall Double Offset Rasp Handle, Left Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall Double Offset Rasp Handle, Left Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall Double Offset Rasp Handle, Left Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall VI DBL OFFST W/ LRG STPL, LT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall Double Offset Rasp Handle, Right Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall Double Offset Rasp Handle, Left Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall Double Offset Rasp Handle, Right Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall Vl DBL OFFST WI LRG STPL, RT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall VER2 DBL OFFSET RASP HANDLE, LT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall VER2 D8L OFFSET RASP HANDLE, RT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left) The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right) The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall VER2 HANDLE, PIN REWORK, LT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall VER2 HANDLE, PIN REWORK, RT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall 23.5 Deg Rasp Handle Assy- LEFT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall 23.5 Deg Rasp Handle Assy- RIGHT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the… Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall BD Multi Check CD4 Low Control The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02 Class IIIFDA’s classAug 20, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 20, 2014ClassClass IIIStatusTerminatedWhereGeorgia, Indiana, Kentucky, Massachusetts, Maryland, Pennsylvania, Texas and Virginia
- Medical device recall Vital Sync” VPMP & IM, software, V2.4. (DVD) Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Georgia, Illinois, Indiana, Louisiana, Mississippi and Texas
- Medical device recall Vital Sync RMS 1.0 when loaded with v2.4 software Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm… Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Georgia, Illinois, Indiana, Louisiana, Mississippi and Texas
- Medical device recall Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges Nanosphere Inc. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, Montana, Ohio, Oklahoma, Oregon, Texas and Utah named
- Medical device recall IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT… The following software issues have been identified in the affected products. Class IIFDA’s classAug 20, 2014in FDA’s Enforcement Report37 statesnamed in where it went PublishedAug 20, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Serrated Soft Tissue Shields Revision B of the tissue shields of the device was 7 mm longer than the previous design. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereFlorida and Missouri
- Medical device recall KODAK DirectView DR 9000 System A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the “Up” or… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC Class IIFDA’s classAug 13, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereArizona, Florida, Idaho, Michigan, Missouri, New Jersey, Ohio and Virginia
- Medical device recall VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and… Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is… Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative… Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INSIGHT Dental Film The Indicator Dot on the film packet’s outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental… Class IIIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 13, 2014ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Ultra-speed Dental Film The Indicator Dot on the film packet’s outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental… Class IIIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 13, 2014ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state “03.7 x 8mm” instead of “04.7 x 8 mm.” Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of… When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an… Class IIFDA’s classAug 13, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereCalifornia, Connecticut and Illinois
- Medical device recall Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide, and Minnesota and Ohio named
- Medical device recall SIEMENS ADVIA Centaur CP Immunoassay System BNP kit Complaints of failed calibration. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall SIEMENS ADVIA Centaur CP Immunoassay System BNP kit Complaints of failed calibration. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Latex Dental Dams labeled as Non-Latex Dental Dams Colt¿ne/Whaledent Inc. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportTennesseethe one state its words name PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific… Product is not approved or authorized for distribution in the US. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Michigan, Mississippi, Nevada, Ohio, Oklahoma, Tennessee and Texas
- Medical device recall Panthera-Puncher 9 Risk of incorrect results from samples prepared with Panthera-Puncher 9 Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 13, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile Labeling error: The manufacturing date is the same as the expiration date. Class IIIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedAug 13, 2014ClassClass IIIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Massachusetts, Missouri, New Jersey, Ohio, Oregon and Texas named
- Medical device recall Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech. The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Class IIFDA’s classAug 13, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedAug 13, 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
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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