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 Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0,… Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11… Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10,… Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil… STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Class IIIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJul 16, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Delaware, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Michigan, New Jersey, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas and Virginia named
- Medical device recall GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476 When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Illinois, Oklahoma, Oregon and Wisconsin
- Medical device recall PALL Medical Breathing Circuit Filter Possible leak from the filter allowing a small of amount of air to be released from the junction between the filter end cap (flat side of the filter) and the… Class IIFDA’s classJul 16, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Texas and Wyoming
- Medical device recall Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit. KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being… Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall ColorSafe IV lines CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereConnecticut, New York and Texas
- Medical device recall The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary… Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, North Carolina, New Jersey, Ohio and Pennsylvania
- Medical device recall The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary… Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices are incorrectly labeled in that the label does not list the… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, North Carolina, New Jersey, Ohio and Pennsylvania
- Medical device recall Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 9, 2014ClassClass IStatusTerminatedWherePuerto Rico
- Medical device recall Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 9, 2014ClassClass IStatusTerminatedWherePuerto Rico
- Medical device recall Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 9, 2014ClassClass IStatusTerminatedWherePuerto Rico
- Medical device recall Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 9, 2014ClassClass IStatusTerminatedWherePuerto Rico
- Medical device recall Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2014in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 9, 2014ClassClass IStatusTerminatedWherePuerto Rico
- Medical device recall NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing,… Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing,… Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing,… Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing,… Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing,… Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing,… Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing,… Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing,… Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing,… Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stirling Ultracold Portable Shuttle, ULT-25 The external power supply input is overheating at the connection to the freezer. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report39 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont and Washington
- Medical device recall illumipro-10 Incubator/Reader, Meridian Bioscience, Inc Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report17 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Iowa, Indiana, Louisiana, Massachusetts, Maine, Michigan, Minnesota, New Jersey, New York, Ohio, Pennsylvania and West Virginia
- Medical device recall Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial Mislabeled. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Pennsylvania and Texas named
- Medical device recall Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral Mislabeled. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Pennsylvania and Texas named
- Medical device recall syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573. Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS)… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Baxter, MiniCap with Povidone-Iodine solution, 5C4466P the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Kansas, Missouri, Mississippi, Tennessee and Texas
- Medical device recall Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide, and Maine and North Carolina named
- Medical device recall Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000,… The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 9, 2014ClassClass IStatusTerminatedWhereNationwide, and Connecticut, Florida, New York, Ohio, Tennessee, Texas and Virginia named
- Medical device recall DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of… A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on… Class IIIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC. Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas and Virginia
- Medical device recall Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas and Virginia
- Medical device recall Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action… Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas and Virginia
- Medical device recall Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical… Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas and Virginia
- Medical device recall Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas and Virginia
- Medical device recall Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas and Virginia
- Medical device recall McKesson Medi-Pak, Laceration Trays with Cotton O.R Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas and Virginia
- Medical device recall Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Tennessee, Texas and Virginia
- Medical device recall Simplexa” Flu A/B & RSV Direct Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa” Flu A/B & RSV Direct (MOL2650). Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrium Express Dry Seal Chest Drain ATS Blood Recovery Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereAlaska, California, Maryland, Minnesota, Missouri, North Carolina, New Jersey, Ohio and Utah
- Medical device recall ADVIA Centaur HCY Diluent - 10mL Bottle ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MIS Rod 2, a component of the NewPort System Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Maryland, Missouri, Tennessee and Texas
- Medical device recall ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system. Class IIFDA’s classJul 9, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 9, 2014ClassClass IIStatusTerminatedWhereCalifornia, Missouri, Pennsylvania, Virginia and West Virginia
- Medical device recall EXACTAMIX 1200 Compounder If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by… Class IIFDA’s classJul 9, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 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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