Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, 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 5, 2026.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Globus Medical MicroFuse Putty, 2.5cc and 10cc The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic RestoreUltra Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic Activa PC Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Carestream DRX-Revolution Mobile X-ray System Carestream Health Inc. Class IIFDA’s classNov 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122 An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maine, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable… OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Massachusetts, Minnesota and Virginia named
- Medical device recall Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900 Some devices may be contaminated on the back side of the device with glue in the blood application area. Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportOhiothe one state its words name PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereOhio
- Medical device recall UNITRAC Pneumatic Retraction Arm Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FSE Image Upgrade Kit The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS)… Class IIIFDA’s classOct 30, 2013in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 30, 2013ClassClass IIIStatusTerminatedWhereFlorida, Iowa, Maine, Missouri, Mississippi, Nebraska, New York, Tennessee, Texas and Washington
- Medical device recall Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T,… There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Kentucky, Mississippi, North Carolina, New Jersey, Pennsylvania, Puerto Rico and Texas named
- Medical device recall Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS) GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio Imaging… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Oklahoma named
- Medical device recall IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System… System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels. Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and New York and Oklahoma named
- Medical device recall STERRAD 200 Sterilizer (Single Door) Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used… Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merit Medical Performa Angiographic Catheter 5F Multipack 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape. Class IIFDA’s classOct 30, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereColorado, Mississippi and Virginia
- Medical device recall STAR Excimer Laser System This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall STAR ActiveTrak Excimer Laser System This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall STAR Excimer Laser System with Variable Spot Scanning This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall STAR Excimer Laser System This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology. Specific error condition could lead to unintended laser emission during laser activation. Class IIFDA’s classOct 30, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereConnecticut, Massachusetts and New York
- Medical device recall Synergetics 25 gauge Soft Tip Cannula One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas. Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Indiana, Kentucky, Louisiana, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania and Tennessee named
- Medical device recall Acuson SC2000 volume imaging ultrasound systems at software version 3.0 Software issue results in inaccurate 3D image may result in ablation in wrong location. Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Illinois, New York, Ohio, Oregon, Pennsylvania and Texas named
- Medical device recall Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the… Alere San Diego, Inc. Class IIIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Integra Licox Brain Tissue Oxygen Monitoring Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra Licox Brain Tissue Oxygen Monitoring Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SmartSet¿ Endurance GMV, Gentamicin The SmartSet¿ GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. Class IIFDA’s classOct 30, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWherePuerto Rico and US Virgin Islands
- Medical device recall VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge… The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare, Aisys, Amingo, Avance, and Avance CS2 GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 23, 2013ClassClass IStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstr¿m ventilator and the Aespire… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedOct 23, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Wisconsin and Wyoming named
- Medical device recall ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 ---… Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that… Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare, Precision 500D, Legacy, RFX, and SFX X GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportDistrict of Columbiathe one state its words name PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereDistrict of Columbia
- Medical device recall Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT… There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds. Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Puerto Rico, Tennessee, Texas, Utah, Virginia, Vermont and West Virginia named
- Medical device recall Synthes Midfoot Fusion Bolt 6.5 mm A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide… Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Iowa, Illinois, Kansas, Massachusetts, Michigan, Pennsylvania, South Carolina and Wisconsin named
- Medical device recall Product Name: OSOM C Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot… Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is… Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible… Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MX 16-Slice CT Scanner System A pinch point at the end of the table top can cause injury. Class IIFDA’s classOct 23, 2013in FDA’s Enforcement Report16 statesnamed in where it went PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kentucky, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania and Virginia
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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