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 IntellaTip MiFi XP Temperature Ablation Catheter Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the… Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall EZPass Suture Retriever, Nitinol, Single Pack The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EZPass Nylon Monofilament Single Pack The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid… The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS (R) Chemistry Products Calibrator Kit 17 Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European… Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS (R) Chemistry Products FS Calibrator 1 Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European… Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and… This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Massachusetts, Maryland, Missouri, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Virginia and Washington named
- Medical device recall iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning… A bug in the software prevents the iGUIDE software from logging off. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Hawaii, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX Potential loss of airway gas measurement in the Compact Airway Gas Modules. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Model Number(s): PB840 Ventilator In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the… Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, West Virginia and Wyoming named
- Medical device recall Safety glasses made with “Rage” frames Fifteen pairs of prescription, safety glasses did not meet required, industrial lens thickness; nor did these glasses have the OSHA-required manufacturer… Class IIFDA’s classJun 25, 2014in FDA’s Enforcement Report12 statesnamed in where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Kansas, Louisiana, Minnesota, New Jersey, Nevada, Ohio, South Carolina and Texas
- Medical device recall Biomet Spine, Cypher MIS Screw Inserter The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spacelabs Healthcare Ventilator Flexport Interface Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been… Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Georgia, Indiana, Louisiana, New York and South Carolina named
- Medical device recall RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use Ability Dynamics is recalling RUSH81 Prosthetic Foot because the existing bolts may be bottomed out in the threaded hole and this could lead to bolt failure. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic… Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic… Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system The keyboard and monitor may not be properly secured to the monitor arm. Class IIIFDA’s classJun 25, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 25, 2014ClassClass IIIStatusTerminatedWhereIowa and New York
- Medical device recall Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components. Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR… Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NIPRO Safe Touch Safety Scalp Vein Set There is a possibility of a crack in the CP luer connector. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458. Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns. Class IIFDA’s classJun 25, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 25, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the… One lot of 3.0mm sized Connectors, Product Reorder No. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 18, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJun 18, 2014ClassClass IStatusTerminatedWhereNorth Carolina
- Medical device recall Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereArizona, Illinois, Massachusetts, Missouri, North Carolina, Oregon, Texas, Virginia and Wisconsin
- Medical device recall Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereArizona, Illinois, Massachusetts, Missouri, North Carolina, Oregon, Texas, Virginia and Wisconsin
- Medical device recall Alere Triage¿ D-Dimer Test PN 98100 Alere initiated this recall because a limited number of Alere Triage¿ D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application… Firm received a complaint that an unreported study performed that day could not be opened from the archive. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement Report47 statesnamed in where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water… Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount… Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Maquet PowerLED 700 Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Armstrong Grommet with wire Otological Ventilation Tube One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall RUSCH Easy Cath Coude Kit, 10 FR Product was packaged with a straight catheter rather than the correct coude (curved) catheter. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Ohio and Oklahoma
- Medical device recall Siemens Healthcare Diagnostics Vista Air Compressor A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereIllinois, Ohio and Tennessee
- Medical device recall VITROS 4600 Chemistry System Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600… Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5600 Integrated System Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600… Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600… Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of… Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a… Software anomaly: potential for delay in the reporting of patient sample test results when using enGen with TCAutomation Software v2.6 , v3.2 and v3.5… Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit Container cap may contain foreign material- 0.60% - 0.80% Manganese Class IIIFDA’s classJun 18, 2014in FDA’s Enforcement ReportMissourithe one state its words name PublishedJun 18, 2014ClassClass IIIStatusTerminatedWhereMissouri
- Medical device recall bluephase style Light probe Pin-point 6>2 mm black A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall enGen (TM) Laboratory Automation System Configured with TCAutomation” Software v3.5 -- For in vitro… Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereArizona, Delaware, North Carolina, Ohio and Tennessee
- Medical device recall BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component:… On 06/08/2011, BioDerm, Inc. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, New Hampshire, New Jersey, New York, Pennsylvania, Texas and Wisconsin named
- Medical device recall BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber… On 06/08/2011, BioDerm, Inc. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, New Hampshire, New Jersey, New York, Pennsylvania, Texas and Wisconsin named
- Medical device recall BioDerm Safe n’ Dry 21006 (Component: SKIN-PREP Protective wipes) On 06/08/2011, BioDerm, Inc. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, New Hampshire, New Jersey, New York, Pennsylvania, Texas and Wisconsin named
- Medical device recall IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX) IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific, NovaGold High Performance Guidewire Neo Metrics, Inc. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg This Lot has variations in melting temperature. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and… There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite” Attachments. Class IIFDA’s classJun 18, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 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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