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 SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages Labeling issue: Product labeled as “Upper” may contain “Lower” archwires with a red midline mark. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Kentucky, Louisiana, Michigan and New York
- Medical device recall SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages Labeling issue: Product labeled as “Upper” may contain “Lower” archwires with a red midline mark. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Kentucky, Louisiana, Michigan and New York
- Medical device recall ABX PENTRA Urine Control L/H HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for… Class IIIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall SmartSite Needleless Connector CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary… The lock pin can become stuck in the “in” position during the manual rotation, resulting in the inability to prone a patient Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas… There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall XiO RTP System When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the… ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the… ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Trifurcated Extension Set CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diagnostic imaging systems (GEMINI LXL The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying… Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereColorado, Florida, Kentucky, Louisiana, Minnesota, Missouri, Ohio and Oklahoma
- Medical device recall LOCATOR¿ Implant Attachment System Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR¿ Implant Attachment Systems because it is currently provided with a label that indicates… Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportOhiothe one state its words name PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereOhio
- Medical device recall The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereAlabama, District of Columbia, Georgia, New Jersey, New York, Oklahoma and Pennsylvania
- Medical device recall Hemochron Jr ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals. Class IIFDA’s classFeb 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed… Carestream received a report of an exposure being initiated without a patient image captured. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Illinois and Texas named
- Medical device recall Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big… The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a reference mAs. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereDistrict of Columbia, Illinois, Indiana, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, Texas and Vermont
- Medical device recall ACUSON SC2000 Ultrasound System The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel,… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number… Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, District of Columbia, Florida, Georgia, Illinois, Massachusetts, Maryland, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Accuray CyberKnife Robotic Radiosurgery System Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AnspacSingle use Sterile bone cutting burs.h Cutter was longer than was stated on the label Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Indiana, Kentucky, Maryland and Texas
- Medical device recall Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs. Cutter was longer than was stated on the label Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Indiana, Kentucky, Maryland and Texas
- Medical device recall Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body… An artifact that resembles thrombus may appear on the image. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Vermont, Washington and West Virginia named
- Medical device recall Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The… Patient images exhibited ring artifacts. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, New York, Oregon and Pennsylvania named
- Medical device recall Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Aquarius (TM) TEMPERATURE THERAPY The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems There is an issue with the Manual Film Composer feature on some CT products. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Florida, Indiana, Kansas, Kentucky, Minnesota, North Carolina, Ohio, Texas and Virginia named
- Medical device recall ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized… bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses… bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and… bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KODAK DirectView DR 7500 Dual Detector System Carestream Health, Inc. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall InnerCool RTx Endovascular System Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Simplexa Flu A/B & RSV Direct assay Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Wisconsin and West Virginia named
- Medical device recall Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or… Maquet Compressor Mini may deliver compressed air at a temperature higher than specified. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be compromised for… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereGeorgia, Illinois, Kentucky, Michigan, Missouri, New Jersey, Tennessee, Utah and Virginia
- Medical device recall Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement Report12 statesnamed in where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereArizona, California, Delaware, Florida, Louisiana, Massachusetts, Maryland, New Jersey, New York, Ohio, Pennsylvania and Texas
- Medical device recall User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software… When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are… The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereArizona, Georgia, Illinois, Indiana, Utah and Wisconsin
- Medical device recall GE Healthcare Innova IGS 630 GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, New Jersey, Nevada, Pennsylvania and Texas named
- Medical device recall GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850 GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico 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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