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 Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in… Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier. Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000,… Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Harvest Graft Delivery System Potential for leur connector to leak or have cracks. Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Georgia, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, New Jersey, New York, Pennsylvania, Texas and Virginia named
- Medical device recall GE, Optima CT660 GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves… Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Missouri, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall GE PET Discovery 610, PET Discovery 710 GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves… Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Missouri, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119 The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time,… Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medical device recall Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not… The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time,… Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medical device recall P21x/5-1 MHz transducer FUJIFILM SonoSite Inc. Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas and West Virginia named
- Medical device recall Bard LifeStent Solo Vascular Stent Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer… During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Ultima OPCAB System, Sterile MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Maryland, New Jersey, New York and Texas named
- Medical device recall King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in… On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of… Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medical device recall Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or… Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Idaho, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall SHOPKO Waterproof Adhesive Pads Antibacterial No antibacterial bandages were packed in boxes labeled as antibacterial. Class IIFDA’s classOct 9, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereIdaho, Indiana, Nebraska and Wisconsin
- Medical device recall The product is labeled in part “***Surgical Laser Technologies, Inc Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier. Class IIFDA’s classOct 9, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereArkansas, Kansas and Ohio
- Medical device recall H&H Emergency Cricothyrotomy Kit (Part No Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is… King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 9, 2013ClassClass IStatusTerminatedWhereNationwide, and Nebraska named
- Medical device recall Product Name: AVEA¿ Ventilator CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 9, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima… Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportDistrict of Columbiathe one state its words name PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereDistrict of Columbia
- Medical device recall Solitaire-35 Peek Solitaire Anterior Spinal System Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant. Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Indiana, Kentucky, Missouri, New York, Oregon, Texas and Wisconsin named
- Medical device recall MedStream Programmable Pump Drug flow rates exceeding programmed flow rates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2013ClassClass IStatusTerminatedWhereNationwide, and Florida, North Carolina, New Jersey and Texas named
- Medical device recall MedStream Programmable Pump Drug flow rates exceeding programmed flow rates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2013ClassClass IStatusTerminatedWhereNationwide, and Florida, North Carolina, New Jersey and Texas named
- Medical device recall MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the… Drug flow rates exceeding programmed flow rates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2013ClassClass IStatusTerminatedWhereNationwide, and Florida, North Carolina, New Jersey and Texas named
- Medical device recall MedStream Refill Kit Drug flow rates exceeding programmed flow rates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2013ClassClass IStatusTerminatedWhereNationwide, and Florida, North Carolina, New Jersey and Texas named
- Medical device recall MedStream Refill Kit Drug flow rates exceeding programmed flow rates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2013ClassClass IStatusTerminatedWhereNationwide, and Florida, North Carolina, New Jersey and Texas named
- Medical device recall MedStream Refill Kit, U.S Drug flow rates exceeding programmed flow rates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2013ClassClass IStatusTerminatedWhereNationwide, and Florida, North Carolina, New Jersey and Texas named
- Medical device recall MedStream Programmable Pump Drug flow rates exceeding programmed flow rates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2013ClassClass IStatusTerminatedWhereNationwide, and Florida, North Carolina, New Jersey and Texas named
- Medical device recall MedStream Programmable Pump Drug flow rates exceeding programmed flow rates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 9, 2013ClassClass IStatusTerminatedWhereNationwide, and Florida, North Carolina, New Jersey and Texas named
- Medical device recall Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field… Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images Class IIFDA’s classOct 9, 2013in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Florida, Illinois, Kentucky, Louisiana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Washington and West Virginia
- Medical device recall NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer:… Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size. Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Lactate Membrane units for E7077 Electrode Radiometer Medical ApS RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass,… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass,… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass,… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for… Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6.,… Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss. Class IIFDA’s classOct 9, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereGuam and Puerto Rico
- Medical device recall DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container,… End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering… Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation Medical device used in cardiovascular procedures is defective. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia 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.”
Your shortlist0 of 4
Add one more to compare.