The Recall Desk

Archive

November 2012 recalls

569 recalls were announced in November 2012.

What the numbers show

Critical
111
Severe
99
High
164
Moderate
162
Low
33

Of the 569 recalls this month scored against our rubric, 20% are Critical, 17% are Severe.

Which agencies issued them

501–569 of 569

  • SevereFDA (Food)·F-0561-2013·2012-11-07

    Harry & David Creamy Caramel Peanut Spread Recalled for Salmonella Risk

    Harry & David is recalling Creamy Caramel Peanut Spread jars and specific gift baskets due to potential Salmonella contamination.

    Product
    Harry & David Creamy Caramel Peanut Spread, 12 oz. jars, labeled in part: "HARRY & DAVID CREAMY CARAMEL PEANUT SPREAD***NET WT 12 OZ (340g)***INGREDIENTS: ROASTEDPEANUTS, SUGAR, CARAMEL COMPOUND***MADE FOR: HARRY AND DAVID MEDFORD, OR 97501***7 80994 75786 8***" The 12 oz. jar
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0577-2013·2012-11-07

    Xan Confections Recalls Dark Peanut Butter Cups Due to Salmonella Risk

    Xan Confections is voluntarily recalling 13 gourmet peanut butter chocolate products, including Dark Peanut Butter Cups, due to potential Salmonella contamination from a supplier.

    Product
    Chocolate, confections. Bulk Dark Peanut Butter Cup, item number 273. 24 pieces per case.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0172-2013·2012-11-07

    Ventlab Stat-Check Resuscitator Recalled for Possible Volume Leakage

    Ventlab Corporation is recalling specific lots of Stat-Check Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.

    Product
    Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0179-2013·2012-11-07

    Ventlab Infant Resuscitator Recalled for Possible Volume Leakage

    Ventlab Corporation is recalling 14,602 infant resuscitators due to possible volume leakage through the inlet valve during bag compressions.

    Product
    Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly ass
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0180-2013·2012-11-07

    Ventlab AirFlow Infant Resuscitator Recalled for Inlet Valve Leakage

    Ventlab is recalling 14,602 AirFlow Infant Resuscitators because the inlet valve may leak air during compressions, potentially compromising respiratory support.

    Product
    AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0575-2013·2012-11-07

    Xan Confections Recalls Peanut Butter Chocolate Due to Salmonella Risk

    Xan Confections is voluntarily recalling 13 peanut butter chocolate products because the peanut butter supplier, Sunland, Inc., recalled its products due to Salmonella contamination.

    Product
    Chocolate, confections. Bulk Milk BigMouth, item number 233. 8 piece per case.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0594-2013·2012-11-07

    Botanical Laboratories Recalls Digestive 3-in-1 Health Liquid Supplement

    Botanical Laboratories Inc. is recalling its Digestive 3-in-1 Health liquid dietary supplement because a raw ingredient tested positive for Salmonella.

    Product
    Product is a liquid dietary supplement packaged in white plastic bottles with a shrink wrap sleeve label. The product comes in 3 sizes, 2 oz, 16oz. and 33.8oz. The product label reads in part: "Fast Absorbing Liquid 1-OZ A DAY***WELLESSE***Digestive 3-in-1 Health Soluble Fiber
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0169-2013·2012-11-07

    Elekta MOSAIQ Medical Record System Recalled for Treatment Data Error

    Elekta, Inc. is recalling MOSAIQ electronic medical record systems because a user error led to a patient being seriously mistreated.

    Product
    MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2013·2012-11-07

    Progressive Medical Recalls Endoscopic Dissector Due to Tip Unraveling Risk

    Progressive Medical Inc is recalling 124 boxes of PMI Endoscopic Dissectors because the tip could come loose or unravel during use.

    Product
    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0588-2013·2012-11-07

    Popcorn Indiana Roasted Peanut Caramel Popcorn Recalled for Listeria Risk

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Roasted Peanut Caramel Popcorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Roasted Peanut Caramel Popcorn Net Wt. 7 oz, UPC 843571003861 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0591-2013·2012-11-07

    Popcorn Indiana Kettlecorn Recalled Due to Listeria Contamination

    Dale & Thomas Popcorn, LLC is recalling various flavors of Popcorn Indiana Kettlecorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Kettlecorn Net Wt. 9.75 oz UPC 84357100050 Net Wt. 14 oz. UPC 843571000693 Net Wt. 8 pack bag 0.7 oz. UPC 843571001676 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0590-2013·2012-11-07

    Popcorn Indiana Kettlecorn Recalled for Listeria Contamination Risk

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Dark Fudge Chocolate Chip Kettlecorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Dark Fudge Chocolate Chip Kettlecorn Net Wt. 5.5 oz, UPC 843571003076 Net Wt. 6 oz UPC Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0589-2013·2012-11-07

    Popcorn Indiana Chocolate Peanut Butter Kettlecorn Recalled for Listeria Contamination

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Chocolate Peanut Butter Kettlecorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Chocolate Peanut Butter Kettlecorn Net Wt 5 oz. UPC 843571003786 Net Wt. 5.5 oz UPC 843571003847 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2013·2012-11-07

    Oscor Recalls Myocardial Heart Wires Due to Spacing Defect

    Oscor, Inc. is recalling specific models of myocardial heart wires because the spacing between the anchoring zig-zag and the electrode is out of specification.

    Product
    Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-0566-2013·2012-11-07

    Guava and Cheese Turnovers Recalled for Undeclared Allergens

    Productos El Gauchito is recalling Guava and Cheese Turnovers due to undeclared milk, wheat, soy, and food dyes.

    Product
    "***Productos El Gauchito Empanadillas Argentinas de Guayaba y Queso (Guava and Cheese Turnovers)***keep frozen or refrigerated***consumer contact: [email protected] Av. Minillas NM-16 Bayamon PR 00956***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0568-2013·2012-11-07

    Cheese and Onion Turnovers Recalled for Undeclared Soy and Dyes

    Productos El Gauchito is recalling cheese and onion turnovers sold in Puerto Rico because the dough shells contain undeclared soy, Yellow #6, and Red #40.

    Product
    "***Productos El Gauchito Empanadillas Argentinas de Queso y Cebolla (Cheese and OnionTurnovers)***keep frozen or refrigerated***consumer contact: [email protected] Av. Minillas NM-16 Bayamon PR 00956***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0583-2013·2012-11-07

    Popcorn Indiana Drizzled Cinnamon Sugar Kettlecorn Recalled for Listeria

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Drizzled Cinnamon Sugar Kettlecorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Drizzled Cinnamon Sugar Kettlecorn Net Wt. 5.5 oz. UPC 843571003052 Net Wt. 6 oz UPC 843571002352 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2013·2012-11-07

    Ventlab Premium Small Adult Resuscitator Recalled for Valve Leakage

    Ventlab Corporation is recalling 14,602 Premium Small Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.

    Product
    Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0593-2013·2012-11-07

    Popcorn Indiana Wasabi Reserve Popcorn Recalled for Listeria Contamination

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Wasabi Reserve Popcorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Wasabi Reserve Popcorn Net Wt. 5.5 oz UPC 843571002048 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0579-2013·2012-11-07

    Xan Confections Recalls Peanut Butter Truffles Due to Salmonella Risk

    Xan Confections is voluntarily recalling 13 peanut butter chocolate products because the peanut butter supplier, Sunland, Inc., recalled its products due to potential Salmonella contamination.

    Product
    Chocolate, confections. Packaged in gift box cartons. 4-Piece Peanut Butter Truffles, item number 079. Labeling reads in part:"ALL NATURAL LadybuG Peanut Butter truffles*** www.XanConfections.com Distributed by: Xan Confections Irvine, CA 92614 U.S.A.***". 4 pieces in each gif
    Category
    Food
    Distribution
    8 states
  • HighCPSC·13029·2012-11-07

    Scuba Diving Hoses Recalled by Three Companies Due to Rupture Hazard

    Innovative Scuba Concepts, Trident Diving, and A-Plus Marine are recalling high-pressure scuba air hoses that can rupture, posing a drowning hazard.

    Product
    High pressure scuba diving air hoses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0585-2013·2012-11-07

    Popcorn Indiana Apple Crisp Popcorn Recalled Due to Listeria Contamination

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Apple Crisp Popcorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Apple Crisp Popcorn Net Wt. 6.5 oz. UPC 843571003243 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0592-2013·2012-11-07

    Popcorn Indiana Salt and Pepper Popcorn Recalled for Listeria Contamination

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Salt and Pepper Popcorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Salt and Pepper Popcorn Net Wt. 6.9 oz UPC 843571003557 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2013·2012-11-07

    Ventlab AirFlow Resuscitator Recalled for Possible Volume Leakage

    Ventlab Corporation is recalling specific lots of AirFlow Small Adult Resuscitators due to possible volume leakage through the inlet valve during compressions.

    Product
    AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversib
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2013·2012-11-07

    Varian ARIA Radiation Oncology Software Recall Due to Treatment Plan Error

    Varian Medical Systems is recalling ARIA Radiation Oncology Version 11 software because monitor units may be incorrect when continuing partial treatment.

    Product
    ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0586-2013·2012-11-07

    Popcorn Indiana Drizzled Black & White Kettlecorn Recalled for Listeria Risk

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Drizzled Black & White Kettlecorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Drizzled Black & White Kettlecorn Net Wt. 6 oz. UPC 843571002345 Canada - Drizzled Black & White Kettlecorn Marbre Noir & Blanc Mais A Marmite Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0567-2013·2012-11-07

    Spinach Turnovers Recalled for Undeclared Soy and Food Dyes

    Productos El Gauchito is recalling Spinach Turnovers sold in Puerto Rico because the dough shells contain undeclared soy and specific food dyes.

    Product
    "***Productos El Gauchito Empanadillas Argentinas de Espinaca (Spinach Turnovers)***keep frozen or refrigerated***consumer contact: [email protected] Av. Minillas NM-16 Bayamon PR 00956***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0558-2013·2012-11-07

    Ma Baensch Marinated Herring Recalled for Undeclared Milk Allergen

    Wild Foods, Inc. is recalling 144 jars of Ma Baensch Marinated Herring in Wine Sauce due to a labeling error involving an undeclared milk allergen.

    Product
    Ma Baensch Marinated Herring in Wine Sauce, Net Wt. 24 oz.. (680g), UPC 714449-10220 in glass jars with gold metal lids.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0170-2013·2012-11-07

    Ventlab Safe Spot Infant Resuscitator Recalled for Valve Leakage

    Ventlab is recalling Safe Spot Infant Resuscitators due to possible volume leakage through the inlet valve during bag compressions.

    Product
    Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of rev
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2013·2012-11-07

    Sorin SCP Pump Control Panel Recalled for Display Malfunction

    Sorin Group USA is recalling 12 SCP Pump Control Panels due to a circuit board defect that may cause display malfunctions and incorrect flow or pressure readings.

    Product
    SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2013·2012-11-07

    Ventlab Premium Small Child Resuscitator Recalled for Valve Leakage

    Ventlab Corporation is recalling 14,602 Premium Small Child Resuscitators due to possible volume leakage through the inlet valve during compressions.

    Product
    Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2013·2012-11-07

    Stryker Spine Recalls Aviator Drill Bits Due to Over-Drilling Risk

    Stryker Spine is recalling Aviator Drill Bits because they are 10 mm longer than Reflex Hybrid bits and not interchangeable, posing a risk of over-drilling.

    Product
    Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allendale NJ 07401-1677 USA +1-201-750-8000 Drill bits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2013·2012-11-07

    Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Connector Detachment Risk

    Maquet Cardiovascular is recalling QUADROX oxygenators because the blood outlet connector may detach from the device during use.

    Product
    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2013·2012-11-07

    Vital Images Recalls Vitrea Software Due to Calcium Score Errors

    Vital Images is recalling Vitrea software versions due to potential errors in calcium score values within restored study snapshots.

    Product
    Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea En
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2013·2012-11-07

    Sorin SCP Pump Control Panel Recalled for Circuit Board Malfunction

    Sorin Group USA is recalling SCP Pump Control Panels due to a circuit board defect that may cause display malfunctions and incorrect flow or pressure readings.

    Product
    SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping thro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0176-2013·2012-11-07

    Ventlab Safe Spot Infant Resuscitator Recalled for Valve Leakage

    Ventlab is recalling Safe Spot Infant Resuscitators due to possible volume leakage through the inlet valve during use.

    Product
    Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2013·2012-11-07

    Ventlab Pro-5000 Adult Resuscitator Recalled for Volume Leakage

    Ventlab Corporation is recalling 14,602 Pro-5000 Series Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.

    Product
    Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2013·2012-11-07

    Ventlab Infant Resuscitator Recalled for Possible Volume Leakage

    Ventlab is recalling 14,602 Safe Spot Infant Resuscitators due to a defect that may cause air to leak through the inlet valve during use.

    Product
    Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0582-2013·2012-11-07

    Popcorn Indiana American Cheese Popcorn Recalled for Listeria Contamination

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana American Cheese Popcorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana American Cheese Popcorn Net Wt. 7 oz. UPC 843571004134 Distributed by Popcorn, Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0565-2013·2012-11-07

    Recall of Caprese Turnovers Due to Undeclared Allergens and Dyes

    Productos El Gauchito is recalling Caprese Turnovers sold in Puerto Rico because they contain undeclared milk, wheat, soy, and food dyes.

    Product
    "***Productos El Gauchito Empanadillas Argentinas Caprese (Caprese Turnovers)***keep frozen or refrigerated***consumer contact: [email protected] Av. Minillas NM-16 Bayamon PR 00956***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0584-2013·2012-11-07

    Popcorn Indiana Almond Biscotti Caramel Popcorn Recalled for Listeria Risk

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Almond Biscotti Caramel Popcorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Almond Biscotti Caramel Popcorn Net Wt. 6.5 oz. UPC 843571003809 Net Wt. 7 oz UPC 843571003854 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0581-2013·2012-11-07

    Popcorn Indiana Bacon Ranch Popcorn Recalled for Listeria Risk

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Bacon Ranch Popcorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Bacon Ranch Popcorn Net Wt. 3.5 oz - UPC 843571001942 Net Wt. 7.75 oz - UPC 843571001935 Net Wt. 8.3oz. - UPC 843571001935 Popcorn, Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0587-2013·2012-11-07

    Popcorn Indiana Caramel Popcorn Recalled for Listeria Contamination

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Caramel Popcorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Caramel Popcorn Net Wt. 7.4 oz. UPC 843571003045 Net Wt. 8 oz - UPC 843571002369 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0580-2013·2012-11-07

    Popcorn Indiana Aged White Cheddar Popcorn Recalled for Listeria

    Dale & Thomas Popcorn, LLC is recalling Popcorn Indiana Aged White Cheddar Popcorn because the manufacturing conveyor belt tested positive for Listeria monocytogenes.

    Product
    Popcorn Indiana Aged White Cheddar Popcorn 0.8 oz - UPC 843571004233 3.5 oz- UPC 843571000532 8 oz- UPC 843571000785 8.3 oz - UPC 843571002956 9 oz - UPC843571000785 Popcorn, Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-035-2013·2012-11-07

    Target UP & UP Kids Foaming Hand Sanitizer Recalled for Microbial Contamination

    DermaCare is recalling 43,272 bottles of UP & UP brand kids' foaming hand sanitizer due to high microbial counts.

    Product
    UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-034-2013·2012-11-07

    Target UP & UP Kids Foaming Hand Sanitizer Recalled for Microbial Contamination

    DermaCare is recalling UP & UP brand kids' foaming hand sanitizer sold at Target due to laboratory findings of high total plate count above specification.

    Product
    UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0183-2013·2012-11-07

    Wright Medical Recalls Hip Components Due to Potential Shelf Life Labeling Errors

    Wright Medical Technology Inc. is recalling 31,566 hip implant components distributed worldwide due to potential inaccuracies in labeled shelf life.

    Product
    Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0162-2013·2012-11-07

    Siemens ADVIA Centaur BR Assay Recalled for Quality Control Issues

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR Assay kits because quality control results fell outside expected ranges.

    Product
    Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Cen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0185-2013·2012-11-07

    Wright Medical Recalls Extremity Components Due to Shelf Life Labeling Errors

    Wright Medical Technology Inc. is recalling 840 units of orthopaedic extremity components because the labeled shelf life may be inaccurate for products packaged in Toulon, France.

    Product
    Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X0941898
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0184-2013·2012-11-07

    Wright Medical Recalls Knee Components Due to Shelf Life Labeling Errors

    Wright Medical Technology Inc is recalling 729 knee components due to potential inaccuracies in labeled shelf life at the Toulon, France facility.

    Product
    Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-036-2013·2012-11-07

    Ben Venue Recalls Leucovorin Calcium Injection Due to Particulate Matter

    Ben Venue Laboratories is recalling 226,010 vials of Leucovorin Calcium Injection due to the presence of visible crystalline particulates.

    Product
    Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2013·2012-11-07

    Ventlab V*Care Infant Resuscitator Recalled for Potential Volume Leakage

    Ventlab Corporation is recalling V*Care Infant Resuscitators due to a possible volume leakage through the inlet valve during compressions.

    Product
    V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0164-2013·2012-11-07

    ConMed Linvatec Recalls Mis-assembled CrossFT Punches for Suture Anchor Insertion

    ConMed Linvatec is recalling 2 units of CrossFT Punches (Lot 330889) because they were mis-assembled with the incorrect handle.

    Product
    "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0168-2013·2012-11-07

    Alphatec Spine Recalls Illico MIS Posterior Fixation System Screws

    Alphatec Spine is recalling 209 Illico MIS Posterior Fixation System screws because a guide-wire fit issue renders them nonfunctional.

    Product
    ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spina
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2013·2012-11-07

    Focus Diagnostics Recalls West Nile Virus IgG Test Kits

    Focus Diagnostics is recalling specific lots of West Nile Virus IgG test kits due to a higher false positive rate.

    Product
    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intend
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0188-2013·2012-11-07

    Roche Recalls cobas 4800 BRAF V600 Mutation Test Kits

    Roche Molecular Systems is recalling 44 kits of the cobas 4800 BRAF V600 Mutation Test because internal-use controls were incorrectly packaged into the product.

    Product
    cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human me
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·12V534000·2012-11-06

    Mitsubishi Fuso Trucks Recalled for Parking Brake Cable Nut Issue

    Mitsubishi Fuso is recalling 2012-2013 trucks because the parking brake cable nut may be loose, risking vehicle rollaway.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO FEC72, FEC52, FEC92, FGB72
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V532000·2012-11-06

    Airstream Recalls 2006-2009 Classic RVs Due to Brake Hose Defect

    Airstream is recalling 2006-2009 Classic recreational vehicles because brake hoses may fail, reducing braking performance and increasing crash risk.

    Product
    AIRSTREAM — AIRSTREAM CLASSIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V533000·2012-11-06

    Mercedes-Benz Recalls 2012 CLS550 Vehicles for Hood Latch Bolt Issue

    Mercedes-Benz is recalling 2012 CLS550 and CLS550 4Matic vehicles because insufficiently tightened hood latch bolts could allow the hood to open while driving, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ CLS550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V535000·2012-11-06

    Fleetwood RV Recalls Motorhomes Due to Weak Entry Step Support

    Fleetwood RV is recalling certain 2010-2013 Storm, Terra, and Encounter motorhomes because the entry step lacks sufficient support and may collapse.

    Product
    FLEETWOOD — FLEETWOOD STORM, TERRA, ENCOUNTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13028·2012-11-06

    Master Forge Gas Grills Recalled for Fire and Burn Hazards

    CPSC recalls about 37,000 Master Forge gas grills sold at Lowe's due to a hose defect that can cause fire and burns.

    Product
    Master Forge Gas Grills
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·12E052000·2012-11-05

    Gates Super-Vac Hoses Recalled for Gasoline Leak Risk in Modified Vehicles

    Hydraulic Supply Co. is recalling Gates Super-Vac hoses used in vehicle modifications for disabled drivers because they are unsuitable for gasoline and may leak.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12C004000·2012-11-02

    Britax Recalls Convertible Child Seats Due to Choking Hazard

    Britax is recalling specific convertible child seats because the chest pads may be chewed into pieces, creating a choking hazard.

    Product
    CHILD SEAT:HARNESS:STRAP/WEBBING recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12E051000·2012-11-02

    Tegol Motorcycle Helmets Recalled for Failing Federal Safety Standards

    Tegol is recalling specific Outlaw Carbon Tech motorcycle helmets because they fail to meet federal safety requirements for impact and retention.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·13022·2012-11-01

    Bose Recalls Dual-Voltage CineMate II Speaker Systems Due to Fire Hazard

    Bose is recalling approximately 20,500 dual-voltage CineMate II home theater speaker systems because a component in the bass module can fail and ignite when used in 220-volt outlets.

    Product
    Dual-Voltage CineMate II Home Theater Speaker Systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13704·2012-11-01

    Excel Industries Recalls Hustler and BigDog Lawn Mowers for Fire Hazard

    Excel Industries is recalling about 18,000 Hustler and BigDog lawn mowers because a fuel tank vent valve fitting can fail to seal, causing a fuel leak and fire hazard.

    Product
    Hustler and BigDog Lawn Mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13025·2012-11-01

    Halloween Mini Projection Lights Recalled for Burn Hazard

    Atico International USA is recalling Halloween Mini Projection Lights sold at Five Below because they can overheat and melt, posing a burn hazard.

    Product
    Halloween Mini Projection Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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