The Recall Desk

Archive

October 2013 recalls

353 recalls were announced in October 2013.

What the numbers show

Critical
3
Severe
124
High
116
Moderate
95
Low
15

Of the 353 recalls this month scored against our rubric, 1% are Critical, 35% are Severe.

Which agencies issued them

101–200 of 353

  • ModerateFDA (Drugs)·D-66207-001·2013-10-30

    Hi-Tech Pharmacal Recalls Subpotent Giltuss and Exactuss Cough Medicines

    Hi-Tech Pharmacal is recalling specific lots of Giltuss and Exactuss cough and cold medicines because they contain less phenylephrine than labeled.

    Product
    GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 0071
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0065-2014·2013-10-30

    Varian Medical Recalls Breast Template System Due to Sterilization Defect

    Varian Medical Systems is recalling 3 sets of the VARISOURCE Breast Template System because the templates may bend and turn opaque after steam sterilization.

    Product
    VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0062-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kit Recall for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0033-2014·2013-10-30

    Philips MRI Systems Recalled for Potential Water Freezing in Venting System

    Philips Medical Systems is recalling 511 MRI systems because water may collect and freeze in the vent pipe, potentially blocking the magnet venting system.

    Product
    Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2014·2013-10-30

    Perkin Elmer 226 Sample Collection Device Recall for Glue Contamination

    Perkin Elmer is recalling 226 Sample Collection Devices used for newborn screening due to potential glue contamination on the back side.

    Product
    Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a te
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0056-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Hex Wrench Defect

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some hex wrenches may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0057-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling 109 Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may fail to loosen the set screw on the drill bit.

    Product
    Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0066-2014·2013-10-30

    GE Brivo C-Arm X-Ray Recalled for High Voltage Cable Failure

    GE is recalling 29 Brivo C-Arm X-ray units because high voltage cable wires may fail, causing loss of system functionality.

    Product
    GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0059-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0029-2014·2013-10-30

    OPTI LION E-Plus Cassettes Recalled for Incorrect Barcode Labeling

    OPTI Medical Systems is recalling OPTI LION E-Plus Cassettes because incorrect barcodes may affect performance over time and cause quality control failures.

    Product
    Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0054-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring kits because a hex wrench may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 085
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0046-2014·2013-10-30

    Abbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor failure on the power distribution board that affects the lamp and illumination system.

    Product
    STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratecto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because a hex wrench may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.ST_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0031-2014·2013-10-30

    Aesculap Recalls UNITRAC Pneumatic Retraction Arms Due to Safety Instructions

    Aesculap, Inc. is recalling 217 UNITRAC Pneumatic Retraction Arms because updated instructions for use are required to ensure safe operation and extend product life.

    Product
    UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0044-2014·2013-10-30

    Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Leak Indicator Issue

    Advanced Sterilization Products is recalling STERRAD 100NX Cassettes because the leak indicator is effective for only 12 months, not the labeled 15 months.

    Product
    STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0064-2014·2013-10-30

    DePuy SmartSet GMV Endurance Gentamicin Bone Cement Recalled for Uncleared Indications

    DePuy Orthopaedics is recalling SmartSet GMV Endurance Gentamicin Bone Cement because it is intended for uses not cleared by the FDA.

    Product
    SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymer
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0035-2014·2013-10-30

    Agfa IMPAX 5.2 DB Server Software Recall for Performance Issues

    Agfa Corp. is recalling IMPAX 5.2 DB Server software because older versions may cause system downtime or slow performance in medical imaging systems.

    Product
    IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0061-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some lots contain a hex wrench that may not loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0010-2014·2013-10-30

    Dean Foods Recalls Fruit Rush Fruit Punch Due to Spoilage Risk

    Dean Foods is recalling Fruit Rush Fruit Punch in Southern California and Arizona because the product may spoil prematurely.

    Product
    Fruit Rush Fruit Punch Artificially Flavored Fruit Drink, One Gallon, Plant 06-704
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-66402-001·2013-10-30

    Tolmar Recalls Subpotent Ketoconazole Shampoo Nationwide

    Tolmar Inc. is voluntarily recalling 391,055 bottles of 2% Ketoconazole Shampoo nationwide because the product was found to be subpotent.

    Product
    Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0032-2014·2013-10-30

    Bio-Rad Recalls FSE Image Upgrade Kits Due to Data Export Issues

    Bio-Rad Laboratories is recalling 23 FSE Image Upgrade Kits because of a software issue that affects data export from the EVOLIS analyzer to Laboratory Information Systems.

    Product
    FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Food)·F-0011-2014·2013-10-30

    Dean Foods Recalls Fruit Rush Lemon Lime Fruit Drink for Spoilage Risk

    Dean Foods is recalling one-gallon Fruit Rush Lemon Lime fruit drinks sold in Southern California and Arizona due to a potential for premature spoilage.

    Product
    Fruit Rush Lemon Lime Artificially Flavored Fruit Drink, One Gallon, Plant 06-704
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-0043-2014·2013-10-30

    Advanced Sterilization Products Recalls STERRAD 200 Sterilizers for Odor Emission

    Advanced Sterilization Products is recalling STERRAD 200 Sterilizers because they may emit unusual odors into the surrounding environment.

    Product
    STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0009-2014·2013-10-30

    Dean Foods Recalls Fruit Rush Black Cherry Fruit Drink for Spoilage Risk

    Dean Foods is recalling one-gallon Fruit Rush Black Cherry fruit drinks due to a potential for premature spoilage. The product was sold in Southern California and Arizona.

    Product
    Fruit Rush Black Cherry Artificially Flavored Fruit Drink, One Gallon, Plant 06-704
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-0053-2014·2013-10-30

    Alere Triage TOX Drug Screen Control 1 Recalled Due to Code Chip Failure

    Alere San Diego, Inc. is voluntarily recalling Alere Triage TOX Drug Screen Control 1 because a provided code chip causes the control to fail in QC Sample Mode.

    Product
    Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V534000·2013-10-29

    Prevost Recalls 2008-2009 Coach Buses Due to Battery Cable Fire Risk

    Prevost is recalling 142 model year 2008-2009 X3-45 and X3-45 Entertainer coach buses because a battery cable may rub against a clamp, causing a short circuit and potential vehicle fire.

    Product
    PREVOST — PREVOST XLII-45 ENTERTAINER, X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V530000·2013-10-29

    Setra Recalls Coaches Due to Electrical Fire Risk

    Setra is recalling specific model year coaches because a battery component may conduct electricity and cause a fire.

    Product
    SETRA — SETRA S407 CC, S417, S417 TC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V489000·2013-10-29

    Hyundai Recalls 2009-2012 Genesis Vehicles for Brake Fluid Defect

    Hyundai is recalling 2009-2012 Genesis vehicles because the brake fluid may not protect against corrosion of the Hydraulic Electronic Control Unit (HECU). This corrosion could reduce brake effectiveness and increase the risk of a crash.

    Product
    HYUNDAI — HYUNDAI GENESIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14007·2013-10-29

    BreathableBaby Recalls Infant Wearable Blankets Due to Choking Hazard

    BreathableBaby is recalling specific infant wearable blankets because zipper parts can detach and pose a choking risk. No injuries have been reported.

    Product
    BreathableSack wearable blanket for infants
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14006·2013-10-29

    Target Recalls Circo Children's Sitting Stools Due to Fall Hazard

    Target is recalling about 69,000 Circo-brand Chloe and Conner sitting stools because the stabilizing bar can crack, causing the stool to collapse and posing a fall hazard to children.

    Product
    Circo-brand Chloe and Conner Sitting Stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V532000·2013-10-29

    Prevost Recalls 81 Coaches Due to Accelerator Pedal Spring Defect

    Prevost is recalling 81 model year 2008-2010 coaches because broken accelerator pedal springs may prevent the pedal from returning to idle, increasing crash risk.

    Product
    PREVOST — PREVOST XLII-45 ENTERTAINER, H3 VIP, X3-45, H3-41
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V540000·2013-10-28

    Forest River Recalls Travel Trailers with Incorrect Tire Pressure Labels

    Forest River is recalling 2008-2011 travel trailers because incorrect tire inflation pressures on the certification label may lead to overinflation and sudden tire failure.

    Product
    ROCKWOOD — ROCKWOOD, FLAGSTAFF, CHEROKEE TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V531000·2013-10-25

    Spartan Motor Home Recall for Potential Steering Linkage Separation

    Spartan is recalling 175 model year 2013-2014 motor homes and one chassis because loose steering linkage fasteners may cause a loss of steering.

    Product
    SPARTAN — SPARTAN MM, K3, K2, METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V526000·2013-10-25

    BMW Recalls 2012 K 1600 GT Motorcycles for Throttle Software Issue

    BMW is recalling 2,475 model year 2012 K 1600 GT and GTL motorcycles because a software error may cause the engine to stall, increasing crash risk.

    Product
    BMW — BMW K 1600 GT, K 1600 GTL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14005·2013-10-24

    Emerson Recalls Tommy Bahama Outdoor Ceiling Fans Due to Injury Risk

    Emerson Air Comfort Products is recalling specific Tommy Bahama outdoor ceiling fans because brackets can break, causing blades to fall and injure bystanders.

    Product
    Tommy Bahama® Outdoor Ceiling Fans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0002-2014·2013-10-23

    Wegmans Apple Cinnamon Mini Muffins Recalled for Undeclared Soy

    Wegmans Food Markets is recalling Apple Cinnamon Mini Muffins because they contain undeclared soy, a known allergen.

    Product
    Wegmans Bakery Mini Muffins APPLE CINNAMON, NET WT 14 OZ (397g) , UPC 77890 18951 --- Baked By Wegmans Food Markets Inc., Rochester, NY 14603
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·13C003000·2013-10-23

    Orbit Baby Recalls G2 Car Seat Bases Due to Knob Defect

    Orbit Baby is recalling specific G2 Car Seat Bases because the StrongArm Knob may detach or spin, potentially failing to secure the base in a crash.

    Product
    CHILD SEAT:BASE recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0014-2014·2013-10-23

    Synthes Midfoot Fusion Bolt Recall for Technique Guide Clarification

    Synthes USA is recalling 62 Midfoot Fusion Bolts to update the technique guide, emphasizing supplemental fixation to reduce the risk of bolt back-out or migration.

    Product
    Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2014·2013-10-23

    GE Healthcare Recalls Anesthesia Devices Due to Tidal Volume Overdelivery Risk

    GE Healthcare is recalling specific anesthesia devices because they may deliver excessive tidal volume in a specific ventilation mode, posing a risk of harm to patients.

    Product
    GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V499000·2013-10-23

    Neo Trailers Recalls 2010-2011 Models Due to Door Lock Jamming Risk

    Neo Manufacturing is recalling 2010-2011 cargo trailers because a defect in Fastec door locks may jam the deadbolt, potentially trapping occupants inside.

    Product
    NEO TRAILERS — NEO TRAILERS NCV, NAS, NAV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V563000·2013-10-23

    Exiss and Sooner Travel Trailer Door Lock Recall

    NHTSA is recalling 2006-2013 Exiss and Sooner travel trailers because a door lock defect may jam the deadbolt, trapping occupants inside.

    Product
    SOONER — SOONER, EXISS TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2014·2013-10-23

    OSOM C. Difficile Toxin A/B Test Kit Recalled for False Negative Risk

    Sekisui Diagnostics is recalling specific lots of the OSOM C. Difficile Toxin A/B Test Kit due to the potential for false negative results.

    Product
    Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2014·2013-10-23

    Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion Risk

    Boston Scientific is recalling TELIGEN implantable cardiac defibrillators because a capacitor defect may cause premature battery depletion.

    Product
    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2014·2013-10-23

    Getinge 46-Series Washer-Disinfectors Recalled for Overheating Risk

    Getinge Disinfection is recalling 46-Series medical washer-disinfectors due to a possible overheating hazard. The voluntary field safety correction affects 143 units distributed in the US and Canada.

    Product
    Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2014·2013-10-23

    GE PET Discovery 610 and 710 Recalled for Image Series UID Conflict

    GE Healthcare is recalling PET scanners because a software issue may cause different image series to share the same ID, potentially leading to incorrect image display.

    Product
    GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V533000·2013-10-23

    Trailex Recalls Enclosed Car Trailers Due to Door Lock Jamming Risk

    Trailex is recalling certain enclosed car trailers because a defect in the door locks may jam the deadbolt, potentially trapping occupants inside.

    Product
    TRAILEX — TRAILEX CTE-80180, CTE-80210 HD, CTE-84180
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2014·2013-10-23

    Siemens Recalls ADVIA Hematology Systems Due to Sample Labeling Error Risk

    Siemens is recalling ADVIA 2120/2120i hematology systems connected to an ADVIA Autoslide because a rack jam error could cause the next slide to be labeled with the wrong sample identification information.

    Product
    ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0005-2014·2013-10-23

    Dutch Valley Mixed Nuts Recalled for Undeclared Pecans

    Dutch Valley Food Development Inc. is recalling Roasted Salted Mixed Nuts with Peanuts due to undeclared pecans in the ingredient statement.

    Product
    Roasted Salted Mixed Nuts w/ Peanuts, net wt. 12 oz., packed in a clear plastic bag. Ingredients: blanched peanuts, unblanched peanuts, unblanched almonds, unblanched Brazil nuts, unblanched filberts, cashews cooked in canola oil, salt. Allergen info: peanut and tree nut
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0003-2014·2013-10-23

    Talenti German Chocolate Cake Gelato Recalled for Undeclared Almonds

    Talenti Gelato is recalling German Chocolate Cake Gelato because the product contains undeclared almonds, a major food allergen.

    Product
    Talenti German Chocolate Cake Gelato, One Pint (473 mL), Crafted By: Talenti, Marietta, GA 30062.
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-0022-2014·2013-10-23

    Harvest Graft Delivery System Recalled for Potential Luer Connector Leaks

    Harvest Technologies is recalling 730 cases of the Harvest Graft Delivery System because the Luer connector may leak or crack.

    Product
    Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0004-2014·2013-10-23

    Dutch Valley Honey Roasted Peanuts Recalled for Undeclared Allergens

    Dutch Valley Food Development Inc. is recalling Honey Roasted Peanuts due to undeclared milk and wheat allergens.

    Product
    Honey Roasted Peanuts, net wt. 11 oz.., packed in a clear plastic bag. Ingredients: peanuts, sugar, peanut and/or canola and/or cottonseed oil, honey, salt, modified potato starch, xanthan gum. Allergen info: peanut and soy ingredients. Also states that facility also pr
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0012-2014·2013-10-23

    GE Healthcare X-ray Systems Recalled for Loose Power Assist Handle Bolts

    GE Healthcare is recalling 810 X-ray systems because internal bolts on the power assist handle may loosen or fall out, potentially causing the handle to stick in the ON position.

    Product
    GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to per
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2014·2013-10-23

    Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion

    Boston Scientific is recalling COGNIS CRT-D devices because a capacitor defect may cause premature battery depletion.

    Product
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0001-2014·2013-10-23

    Hartley's Potato Chips Recalled for Undeclared Milk Allergen

    Hartley's Salt & Vinegar Potato Chips are being recalled because they contain undeclared lactose, a milk allergen, in the seasoning.

    Product
    Hartley's Potato Chips Salt & Vinegar 4.5 oz and 2.5 oz bags Hartley's Potato Chip Co., Inc, Lewistown, PA Ingredients: potatoes, vegetable shortening, salt, lactose, sodium diacetate, salt, malic acid, sodium citrate, with not more than 2% silicon dioxide and partially hydr
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-66272-001·2013-10-23

    Infant ibuprofen drops are recalled nationwide for process-related particulates

    McNeil Consumer Healthcare is recalling 197,532 bottles of Concentrated Motrin Infants' Drops because process-related particulates were observed. The affected bottles were distributed nationwide.

    Product
    Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by McNeil Consumer Healthcare, Fort Washington, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2014·2013-10-23

    Philips MX 16-Slice CT Scanner Recalled for Pinch Point Injury Risk

    Philips Medical Systems is recalling 326 MX 16-Slice CT Scanner Systems because a pinch point at the end of the table top can cause injury.

    Product
    MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0021-2014·2013-10-23

    GE Healthcare Recalls X-ray Systems Due to Missing Monitor Screws

    GE Healthcare is recalling specific X-ray imaging systems because missing screws in the overhead video monitor suspension could create a safety hazard.

    Product
    GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0013-2014·2013-10-23

    Philips CT Scanners Recalled for Image Artifacts During Specific Scans

    Philips is recalling 258 CT scanners because artifacts appear on images during threshold-triggered bolus scans using a 0.4-second rotation time.

    Product
    Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cros
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0023-2014·2013-10-23

    GE Optima CT660 Recalled for Potential Series UID Generation Error

    GE Healthcare is recalling Optima CT660 scanners because the DMPR and Screen Save functions may generate duplicate Series UIDs, potentially causing PACS systems to combine patient series incorrectly.

    Product
    GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2014·2013-10-23

    GE Healthcare Recalls Ventilators and Anesthesia Machines with Unresponsive Buttons

    GE Healthcare is recalling 911 ventilators and anesthesia machines because manufacturing defects may cause display buttons to fail, preventing access to menu functions.

    Product
    GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0017-2014·2013-10-23

    Siemens Recalls Dimension Vista Urinary Protein Reagent Cartridges

    Siemens is recalling Dimension Vista Urinary/Cerebrospinal Fluid Protein reagent cartridges due to confirmed absorbance errors during calibration.

    Product
    Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2014·2013-10-23

    Abbott Clinical Chemistry Phosphorus Reagent Recalled for Incorrect Expiration Dates

    Abbott Laboratories is recalling specific lots of Clinical Chemistry Phosphorus Reagent because the supplier assigned incorrect expiration dates to the product.

    Product
    Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0027-2014·2013-10-23

    SonoSite P21x/5-1 Transducer Recalled for Biopsy Bracket Sensor Defect

    SonoSite, Inc. is recalling 10 P21x/5-1 MHz transducers because the Biopsy Bracket Sensor is not working as intended.

    Product
    P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V525000·2013-10-22

    Pierce Cab Tilt Mounts May Fail During Maintenance

    Pierce is recalling specific Lance, Enforcer, Dash, and Arrow XT vehicles because cab tilt mounts may fail, causing the cab to fall and potentially injure nearby personnel.

    Product
    PIERCE — PIERCE LANCE, ENFORCER, DASH, ARROW XT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V518000·2013-10-22

    Pierce Recalls 2009-2013 Vehicles Due to Trailer Turn Signal Defect

    Pierce is recalling certain 2009-2013 vehicles because trailer turn signals may not display when brakes are applied, increasing crash risk.

    Product
    PIERCE — PIERCE QUANTUM, SABER, VELOCITY, IMPEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V520000·2013-10-18

    Glaval Transit Buses Recalled for Electrical Fire Risk

    Glaval Bus is recalling 2009-2010 transit buses equipped with specific electric door actuators due to a risk of electrical fire caused by overheating circuit boards.

    Product
    GLAVAL — GLAVAL, GLAVAL BUS UNIVERSAL, TITAN, TITAN II, SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V514000·2013-10-18

    Jayco Recalls 2014 Jay Flight Trailers Due to Fire Risk

    Jayco is recalling 2014 Jay Flight and Jay Flight Swift travel trailers because improper wire insulation may cause excessive heat and increase the risk of fire.

    Product
    JAYCO — JAYCO JAY FLIGHT SWIFT, JAY FLIGHT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V449000·2013-10-18

    Suzuki Recalls GSX-R Motorcycles Due to Front Brake Master Cylinder Defect

    Suzuki is recalling 2004-2013 GSX-R600, GSX-R750, and 2005-2013 GSX-R1000 motorcycles because corrosion in the front brake master cylinder may reduce braking power.

    Product
    SUZUKI — SUZUKI GSX-R750, GSX-R600, GSX-R1000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V524000·2013-10-18

    Turtle Top Recalls 2009 Ford Odyssey LT Buses for Fire Risk

    Turtle Top is recalling 2009 Ford Odyssey LT transit buses because voltage spikes may damage door actuator circuit boards, increasing the risk of fire.

    Product
    TURTLE TOP — TURTLE TOP FORD ODYSSEY LT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V522000·2013-10-18

    RC and MTI Enclosed Trailers Recalled for Door Lock Defect

    RC Trailers is recalling 2006-2013 RC and MTI enclosed trailers because a door lock defect could jam the deadbolt, trapping occupants inside.

    Product
    MTI — MTI, RC ENCLOSED TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E054000·2013-10-17

    Meritor Recalls 2012 FCCC MC Trucks Due to Axle Hub Defect

    Meritor is recalling 2012 FCCC MC trucks because a missing locking snap ring on the axle hub could cause rear wheels to separate, increasing crash risk.

    Product
    FCCC — FCCC MC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E055000·2013-10-17

    ILJIN Recalls Front Wheel Bearings with Defective Speed Sensor Wiring

    ILJIN USA Corporation is recalling specific SKF and Federal Mogul front wheel bearings produced in 2013 due to reversed sensor wires that disable the antilock brake system.

    Product
    SERVICE BRAKES, HYDRAULIC:ANTILOCK/TRACTION CONTROL/ELECTRONIC LIMITED SLIP:WHEEL SPEED SENSOR/TONE RING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V495000·2013-10-17

    Spartan Motors Recalls Transit Bus Chassis Cabs Due to Brake Cable Defect

    Spartan Motors is recalling 2011-2013 Transit Bus Chassis Cabs because the park brake cable may rub against the hydraulic brake line, potentially causing a loss of rear brakes.

    Product
    SPARTAN MOTORS — SPARTAN MOTORS TRANSIT BUS CHASSIS CAB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V487000·2013-10-17

    New Flyer Recalls 2013 Buses Due to Air Brake Line Installation Error

    New Flyer is recalling 119 model year 2013 buses because incorrectly installed air lines may cause a loss of service braking, increasing crash risk.

    Product
    NEW FLYER — NEW FLYER XD60, XN40, XDE40, XD40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13T008000·2013-10-17

    Hankook Recalls Dynapro MT Tires Due to Tread Separation Risk

    Hankook is recalling specific Dynapro MT tires manufactured between August 2011 and September 2013 because they may develop tread separation, which can lead to tire failure and loss of vehicle control.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V442000·2013-10-17

    Toyota Recalls 2012-2013 Avalon, Camry, Venza for Airbag Risk

    Toyota is recalling 2012-2013 Avalon, Camry, and Venza vehicles because a clogged air conditioning drain hose may cause water to leak onto the airbag control module, potentially disabling airbags or causing them to deploy unexpectedly.

    Product
    TOYOTA — TOYOTA AVALON, CAMRY, VENZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E056000·2013-10-17

    Wheel Pros Recalls Moto Metal 8-Lug Wheels Due to Cracking Risk

    Wheel Pros, LLC is recalling Moto Metal-brand 8-Lug bolt pattern wheels, model MO909, because they are susceptible to cracking, which could lead to a loss of vehicle control.

    Product
    WHEELS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V503000·2013-10-17

    Altec Recalls 2008-2010 Wood Chippers Due to Axle Bracket Cracks

    Altec is recalling 2008-2010 WC126 and WC166 wood chippers because axle brackets may crack and break, potentially causing the axle to separate and increasing crash risk.

    Product
    ALTEC — ALTEC WC126, WC166A, WC126A, WC166
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V501000·2013-10-17

    Cheetah 20-40 FT Maximizer Trailer Recall for Pin Weld Failure

    Cheetah Chassis is recalling 2010-2014 20-40 FT Maximizer trailers because a weld may fail, causing parts to separate and potentially injure people or damage other vehicles.

    Product
    CHEETAH — CHEETAH 20-40 FT MAXIMIZER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V507000·2013-10-17

    Ural Motorcycles Recalled for Defective Aluminum Rims

    Irbit Motorworks is recalling 2012 Ural motorcycles with sidecars because improperly heat-treated aluminum rims may crack or break, increasing crash risk.

    Product
    URAL — URAL TOURIST-T, PATROL-T, PATROL, TOURIST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V498000·2013-10-17

    MCI Recalls Coaches with Defective Battery Equalizers

    Motor Coach Industries is recalling specific model year 2000-2012 coaches equipped with Sure Power battery equalizers that may conduct electricity after heat exposure.

    Product
    MCI — MCI D4000, 102EL3, J4500C, 102ELS3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V484000·2013-10-17

    Bentley Recalls 2007-2011 Continental Models Due to Brake Screw Failure

    Bentley is recalling 469 vehicles from 2007-2011 because brake rotor screws may fail in salty conditions, reducing braking ability and increasing crash risk.

    Product
    BENTLEY — BENTLEY CONTINENTAL FLYING SPUR, CONTINENTAL GT CABRIO, CONTINENTAL GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V492000·2013-10-17

    Mack Trucks Recalls 2013-2014 Models Due to Axle Nut Defect

    Mack Trucks is recalling 1,155 model year 2013-2014 vehicles because axle spindle nuts may loosen, potentially causing the hub assembly to separate and increasing crash risk.

    Product
    MACK — MACK CHU, PINNACLE (CXU), GRANITE (GU), LEU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V480000·2013-10-17

    Blue Bird Recalls Commercial Buses Due to Fire Risk in Battery Equalizers

    Blue Bird is recalling specific commercial buses because a battery equalizer component may conduct electricity after heat exposure, increasing the risk of a fire.

    Product
    BLUE BIRD — BLUE BIRD EXPRESS 4500, EXPRESS 4000, ULTRA LF, ULTRA LMB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V513000·2013-10-17

    Outlaw Recalls Horse Trailers with Defective Door Locks

    Outlaw Conversions is recalling 2006-2013 horse trailers with Fastec door locks that may jam, potentially trapping occupants inside.

    Product
    PLATINUM — PLATINUM, 4-STAR, HART HORSE TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V502000·2013-10-17

    Porsche Recalls 2014 Models Due to Passenger Airbag Wiring Defect

    Porsche is recalling certain 2014 Boxster, Cayman, and 911 Carrera vehicles because defective wiring may deactivate the front passenger airbag, increasing injury risk in a crash.

    Product
    PORSCHE — PORSCHE CAYMAN, BOXSTER, 911 CARRERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V510000·2013-10-17

    Northwood Recalls Trailers With Defective Door Locks That May Jam

    Northwood is recalling specific travel trailers and campers because a defect in the door locks may jam the deadbolt, potentially trapping occupants inside.

    Product
    WOLF CREEK — WOLF CREEK, FOX MOUNTAIN, ARCTIC FOX PICKUP CAMPER, FIFTH WHEEL, TOY HAULER, TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V497000·2013-10-17

    Fontaine Recalls Modified Volvo VAH Trucks Due to Fire Risk

    Fontaine Modification is recalling 2011-2013 Volvo VAH trucks with upward-facing exhaust diffusers because heat may transfer to the cab roof, posing a fire risk.

    Product
    VOLVO — VOLVO VAH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V517000·2013-10-17

    Harley-Davidson Recalls 2014 Motorcycles Due to Clutch Release Plate Defect

    Harley-Davidson is recalling 2,886 model year 2014 motorcycles because an incorrect clutch release plate may prevent the clutch from disengaging, increasing crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FXSBSE, FLSTNSE, FLHTCUTG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V490000·2013-10-17

    KZRV Travel Trailer Recall for Door Lock Jamming Hazard

    KZRV is recalling 2006-2013 travel trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside.

    Product
    KZRV — KZRV TOWABLE TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V445000·2013-10-17

    Nissan Recalls 2013-2014 Pathfinder, QX60, and JX35 for ABS Software Issue

    Nissan is recalling certain 2013-2014 Pathfinder, Infiniti QX60, and JX35 vehicles because ABS software may increase stopping distance during light braking on rough roads.

    Product
    NISSAN — NISSAN, INFINITI PATHFINDER, QX60, JX35
    Category
    Vehicle
    Distribution
    Distributed nationwide

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