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 7, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall AlloFuse DBM Putty 5cc The donor was hemodiluted. Class IIFDA’s classMay 14, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 14, 2014ClassClass IIStatusTerminatedWhereNationwide, and Colorado and Michigan named
- Medical device recall Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106 Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. Class IIFDA’s classMay 14, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedMay 14, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Siemens ADVIA Centaur Folate Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219… Class IIFDA’s classMay 14, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in… It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly… Class IIFDA’s classMay 14, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 14, 2014ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Illinois, Massachusetts, Missouri, Oklahoma, Oregon and Texas named
- Medical device recall Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable… Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the… Class IIFDA’s classMay 14, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 14, 2014ClassClass IIStatusTerminatedWhereNationwide, and North Dakota, New Mexico, Rhode Island and Vermont named
- Medical device recall Shimadzu Digital Radiography X-Ray System Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances. Class IIFDA’s classMay 14, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic SynchroMed¿ II Implantable Drug Infusion Pump This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Class IIFDA’s classMay 14, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 14, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell… Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMay 7, 2014ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red… Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMay 7, 2014ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical… Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down… Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE Healthcare, CardiacVX [CardiacVX GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on… Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportIndianathe one state its words name PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereIndiana
- Medical device recall GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such… There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2014in FDA’s Enforcement Report53 statesnamed in where it went PublishedMay 7, 2014ClassClass IStatusTerminatedWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ExacTrac 6.0 is a patient positioning and monitoring system When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment… Class IIFDA’s classMay 7, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Louisiana, Massachusetts, Ohio, Texas and Wisconsin
- Medical device recall HexaPOD evo RT Couchtop If screws are not properly tightened with a torque wrench they may become loose over time. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement Report29 statesnamed in where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS… Manufacturing of these devices with a grade of stainless steel that is not within specifications. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Louisiana, Michigan, Minnesota, Missouri, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall The Acumed Tension Band Pin is a fixation pin which is .0625” in diameter and is available in lengths between… Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within… Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Louisiana, Michigan, Minnesota, Missouri, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington and Wyoming named
- Medical device recall IMMULITE /IMMULITE 1000 Systems TIE Total IgE Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VITROS Chemistry Products Specialty Diluent Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS… Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS Chemistry Products FS Diluent Pack 3 Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS… Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter,… A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra CUSA Excel Disposable Wrench Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic neurostimulators Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be… Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Medtronic Activa RC Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be… Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Medtronic, External neurostimulator, ENS Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be… Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall PolypVac 3.5mm Microdebrider The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle. Class IIIFDA’s classMay 7, 2014in FDA’s Enforcement Report11 statesnamed in where it went PublishedMay 7, 2014ClassClass IIIStatusTerminatedWhereArizona, California, Florida, Idaho, Illinois, North Carolina, Oregon, Pennsylvania, Texas, Virginia and Vermont
- Medical device recall Alfa Wassermann Diagnostic Technologies, LLC Extremely low absorbance readings. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alfa Wassermann Diagnostic Technologies, LLC Extremely low absorbance readings. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND) Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE… Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND) Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE… Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option,… GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereDistrict of Columbia, Guam and Puerto Rico
- Medical device recall CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri and North Carolina named
- Medical device recall Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture… The product did not meet minimum and/or average minimum Teleflex resorption strength requirements. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri and North Carolina named
- Medical device recall Anti EpCam PE - Analyte Specific Reagent Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE. Class IIFDA’s classMay 7, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedMay 7, 2014ClassClass IIStatusTerminatedWhereArizona, California, Florida, Michigan, Missouri, New York and Texas
- Medical device recall Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) The housing to the Pump’s driveline connector became partially or fully separated from the front portion of the driveline connector. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedApr 30, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Fassier-Duval IM Telescopic System The outer package label contained the incorrect length of the device. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box A reagent contained within the product may return false negative results. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement Report11 statesnamed in where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Massachusetts, Maine, New Jersey, Pennsylvania, Tennessee, Texas, Virginia and Vermont
- Medical device recall Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box A reagent contained within the product may return false negative results. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement Report11 statesnamed in where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Massachusetts, Maine, New Jersey, Pennsylvania, Tennessee, Texas, Virginia and Vermont
- Medical device recall ZYM B Reagent (REF 70493) bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedApr 30, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall FB Reagent (REF 70562) bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedApr 30, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall API NIH (REF 10400) bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedApr 30, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall API Listeria (REF 10300) bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedApr 30, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LifeShield LATEX-FREE HemoSet 100 mL Burette I.V Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a… Class IIFDA’s classApr 30, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereFlorida, Iowa, Indiana, Kansas, Kentucky, Maine, Missouri, Montana, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and… Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software RaySearch Laboratories has recalled “RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0” software due to dose miscalculations for bolus/external/fixation support… Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Illinois, Massachusetts, Maryland, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Virginia and Washington named
- Medical device recall SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric… Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 30, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Merit Laureate Hydrophilic Guide Wire Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035” 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a… Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merit Laureate 0.035” Merit Medical Systems, Inc. Class IIFDA’s classApr 30, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 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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