The Recall Desk

Archive

March 2013 recalls

461 recalls were announced in March 2013.

What the numbers show

Critical
39
Severe
115
High
192
Moderate
84
Low
31

Of the 461 recalls this month scored against our rubric, 8% are Critical, 25% are Severe.

301–400 of 461

  • HighNHTSA·13V094000·2013-03-14

    Nissan Recalls 2013 Titan and NV Trucks for Shift Lever Defect

    Nissan is recalling 2013 Titan trucks and NV vans because a shift lever defect may allow the vehicle to roll away without the brake being applied.

    Product
    NISSAN — NISSAN TITAN, NV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1037-2013·2013-03-13

    Tropical Nut & Fruit Recalls Granulated Peanuts Due to Salmonella Risk

    Tropical Nut & Fruit Inc is recalling granulated peanuts in 1 lb bags because they were made with peanut products recalled for potential Salmonella contamination.

    Product
    Granulated Peanuts in 1 lb plastic bags.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1044-2013·2013-03-13

    Gorant Candies Recalls No Sugar Added Milk Chocolate Peanuts

    Gorant Candies is recalling No Sugar Added Milk Chocolate Peanuts because the peanuts used may be contaminated with Salmonella.

    Product
    No Sugar Added Milk Chocolate Peanuts in 10 oz and 3 oz bags
    Category
    Food
    Distribution
    29 states
  • CriticalFDA (Food)·F-1040-2013·2013-03-13

    BA Sweetie Candy Co Recalls Chocolate Bridge Mix Due to Salmonella Risk

    BA Sweetie Candy Co is recalling Sugar Free/NSA Chocolate Bridge Mix because it was made with peanut products that may be contaminated with Salmonella.

    Product
    Sugar Free/ NSA Chocolate Bridge Mix in plastic bags 2 lb, UPC 0 17598 94258 2, 5 lb, UPC 017598 04258 9
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1041-2013·2013-03-13

    BA Sweetie Candy Co Recalls Chocolate Peanuts Due to Salmonella Risk

    BA Sweetie Candy Co is recalling Sweetie Sugar Free/NSA Chocolate Peanuts because they were made with peanut products recalled by Peanut Corporation of America for potential Salmonella contamination.

    Product
    Sweetie Sugar Free/ NSA Chocolate Peanuts in plastic bag 2 lb, UPC 0 17598 94259 9, 5 lb, UPC 0 17598 04259 6
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1038-2013·2013-03-13

    BA Sweetie and Dave's Market Peanuts Recalled for Salmonella Risk

    BA Sweetie Candy Co is recalling specific peanut products because they were made with ingredients from a previous recall that may contain Salmonella.

    Product
    B. A. Sweetie Double Dip Peanuts in plastic bags 2 lb, UPC 0 17598 90687 4, 5 lb, UPC 0 17598 00687 1; & Dave's Market Chocolate Double Dip Peanuts in plastic bags, 4 oz, UPC 017598 70687 0
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1042-2013·2013-03-13

    Gorant Chocolate Bridge Mix Recalled Due to Salmonella Risk

    Gorant Candies Inc is recalling chocolate bridge mix because it was made with peanuts potentially contaminated with Salmonella.

    Product
    Chocolate bridge mix in 10 oz, 3 oz, and 3.5 oz bags
    Category
    Food
    Distribution
    29 states
  • CriticalFDA (Food)·F-1047-2013·2013-03-13

    UpRiver Cold Smoke Atlantic Salmon Recalled for Listeria

    Mkg Provisions Inc is recalling UpRiver brand Cold Smoke Atlantic Salmon because lab samples tested positive for Listeria monocytogenes.

    Product
    UpRiver brand Cold Smoke Atlantic Salmon Pre-sliced Vacuum Packed, 4 oz..
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1048-2013·2013-03-13

    UpRiver Cold Smoke Atlantic Salmon Recalled for Listeria

    Mkg Provisions Inc is recalling UpRiver brand Cold Smoke Atlantic Salmon Balik Cut Sides because lab samples tested positive for Listeria monocytogenes.

    Product
    UpRiver brand Cold Smoke Atlantic Salmon Balik Cut Sides Vacuum Packed
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1031-2013·2013-03-13

    Giannios Candy Recalls Chocolate and Peanut Products Due to Salmonella Risk

    Giannios Candy Co Inc is recalling specific chocolate and peanut products because they were made with peanut butter that may be contaminated with Salmonella.

    Product
    Milk Chocolate Catalog # 111, Dark Chocolate Peanut Clusters Catalog # 112 & Peanut Butter Pieces Catalog # 107 individually wrapped. Date Codes 121401-130831
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1039-2013·2013-03-13

    BA Sweetie Chocolate Bridge Mix Recalled Due to Salmonella Risk

    BA Sweetie Candy Co is recalling specific bags of Chocolate Bridge Mix because they were made with peanut products potentially contaminated with Salmonella.

    Product
    B. A. Sweetie Chocolate Bridge Mix in plastic bags 2 lb, UPC 0 17598 90609 6, 5 lb, UPC 0 17598 00609 3; & Dave's Markets Chocolate Bridge Mix in plastic bags, 4 oz, UPC 017598 70609 2.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1043-2013·2013-03-13

    Gorant Candies Recalls Milk Chocolate Peanuts Due to Salmonella Risk

    Gorant Candies is recalling specific bags of Milk Chocolate Peanuts because they were made with peanuts potentially contaminated with Salmonella.

    Product
    Milk Chocolate Peanuts in 10 oz, 3 oz, and 5 oz bags
    Category
    Food
    Distribution
    29 states
  • CriticalFDA (Food)·F-1049-2013·2013-03-13

    Mkg Provisions Recalls Cold Smoke Atlantic Salmon Due to Listeria

    Mkg Provisions Inc is recalling Cold Smoke Atlantic Salmon because lab samples tested positive for Listeria monocytogenes. The product was distributed in Florida and Illinois.

    Product
    Cold Smoke Atlantic Salmon Nordic Choice Pre-sliced Vacuum Packed
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-183-2013·2013-03-13

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Hospira Inc. is recalling 325,056 bags of 0.9% Sodium Chloride Injection USP, 100 mL, due to a potential lack of assurance of sterility.

    Product
    0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1036-2013·2013-03-13

    Ocean Beauty Seafoods Recalls Cold Smoked Sockeye Salmon for Listeria

    Ocean Beauty Seafoods is recalling 336 pounds of Csea brand Cold Smoked Smoked Sockeye Trim because a surveillance sample tested positive for Listeria monocytogenes.

    Product
    Cold-smoked salmon in a vacuum packed, clear plastic bag. Product labeled: Csea brand Cold Smoked Smoked Sockeye Trim, 2 lb., Ingredients: Sockeye Salmon, Salt, and Natural Hardwood Smoked Produced by Ocean Beauty Seafoods, LLC KEEP REFRIGERATED AT 38 DEG OR BELOW"
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1052-2013·2013-03-13

    Rich Products Recalls Frozen Ancient Grain Bread Dough Due to Metal Fragments

    Rich Products Corp is recalling approximately 6,000 cases of frozen Ancient Grain Bread dough because it was manufactured with flour containing metal fragments.

    Product
    ALL NATURAL ANCIENT GRAIN BREAD, NET WT. 13.8 OZ. (393 g), PRODUCT OF CANADA, UPC 0 49800 08712 5 (appears on bag), Product Code 08712 --- RICH PRODUCTS CORP., BUFFALO, NY 14213 --- The product is a frozen bread dough packaged in a plastic bag with 24 plastic bags per case. The
    Category
    Food
    Distribution
    18 states
  • SevereNHTSA·13E014000·2013-03-13

    Emerson Recalls Fisher Pressure Relief Valves for Cargo Tank Trailers

    Emerson is recalling Fisher-branded H732 and H832 pressure relief valves used in cargo tank trailers because the valve stem may break, potentially ejecting the valve and releasing pressurized gas.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1053-2013·2013-03-13

    Sara Lee Multi-Grain Buns Recalled Due to Metal Fragments

    Rich Products Corp is recalling Sara Lee Thin Style Buns because bulk flour contained stainless steel fragments from a faulty screen.

    Product
    Sara Lee Thin Style Buns, 100% Multi-Grain, 1.5 oz., Goglanian Bakeries Product Code 77474, UPC 072945611788 --- The product is packaged in a plastic bag with a green bag clip. There are 8 buns per retail package (plastic bag) and there are 18 bags per tray.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-184-2013·2013-03-13

    Hospira Recalls HEXTEND Hetastarch Bags Due to Sterility Concerns

    Hospira is recalling 11,412 bags of HEXTEND (Hetastarch) 6% Injection due to a potential leak from the fill tube seal that compromises sterility.

    Product
    HEXTEND — HEXTEND (HETASTARCH)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1058-2013·2013-03-13

    Decoty Taco Seasoning Recalled for Undeclared Soy Ingredient

    Decoty Coffee Company is recalling 1.25 lb and 5.75 lb taco seasoning containers due to undeclared soy, posing a risk to individuals with soy allergies.

    Product
    Taco Seasoning, Net Wt. 1.25 lb and 5.75 lb. Distributed by Decoty Coffee Company, San Angelo, TX 76903, 800-588-8001. The products come in 1.25lb and 5.75lb sizes and are distributed in plastic spice containers with resealable lids.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2013·2013-03-13

    Ethicon PSX PROXIMATE Skin Staple Extractor Recalled for Sterility Concerns

    Ethicon Endo-Surgery is recalling PSX PROXIMATE Skin Staple Extractors because packaging damage may have compromised the sterility of the devices.

    Product
    PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-0906-2013·2013-03-13

    Philips CT System Software Recall for Incorrect Value Display

    Philips is recalling 2,580 Extended Brilliance Workspace CT systems to fix a software defect that may display incorrect values.

    Product
    Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstructi
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-1059-2013·2013-03-13

    Herbalife Formula 1 Vanilla Dream Shake Mix Recalled for Undeclared Milk

    Herbalife is recalling Formula 1 Vanilla Dream Shake Mix packets due to trace amounts of undeclared milk protein.

    Product
    HERBALIFE Formula 1 Instant Healthy Meal, Nutritional Shake Mix ( Vanilla Dream) Packets; net WT 1.83 oz/52 g; packaged as 12 packets in a cardboard carton; just add water; single serve powder in a packet;
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0901-2013·2013-03-13

    GE Healthcare Recalls Advantage Workstation Volume Viewer Software

    GE Healthcare is recalling Advantage Workstation Volume Viewer software due to potential safety issues that may result in incorrect views and measurements.

    Product
    GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast,
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0908-2013·2013-03-13

    Medtronic DPL Single Stage Venous Cannula Recalled for Rough Metal Edges

    Medtronic is recalling DPL Single Stage Venous Cannulas used in cardiopulmonary bypass due to potential rough metal edges on the tip side ports.

    Product
    Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1056-2013·2013-03-13

    Z Pro 25 High Protein Supplement Recalled for Undeclared Allergens

    R-Kane Products Inc. is recalling Z Pro 25 High Protein Supplement because it contains undeclared milk and coconut allergens.

    Product
    Z Pro 25 High Protein Supplement Net. Wt. 1.3 oz. - Vanilla Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1055-2013·2013-03-13

    Bruce Foods Recalls Enchilada Sauce for Undeclared Soy and Wheat

    Bruce Foods Corp is recalling Food Club Mexican Style Enchilada Sauce due to undeclared soy and wheat allergens.

    Product
    Food Club(R) MEXICAN STYLE ENCHILADA SAUCE, RED, NET WT 10 OZ (284g), DISTRIBUTED BY TOPCO ASSOCIATES LLC, 7711 GROSS POINT RD., SKOKIE, IL 60077 UPC: 036800292208
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1054-2013·2013-03-13

    Rich Products Recalls Daphne's Multigrain Flatbread Due to Metal Fragments

    Rich Products Corp is recalling Daphne's California 6 inch Multigrain Flatbread because the bulk flour used contained stainless steel fragments.

    Product
    Daphne's California 6 inch Multigrain Flatbread, 2.1 oz., Product Code 77468, Net Wt. 13.50 lbs. (case) --- There are 12 - 10 count bags per case
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1057-2013·2013-03-13

    R-Kane Z Pro High Protein Supplement Recalled for Undeclared Allergens

    R-Kane Products Inc. is recalling Z Pro 25 High Protein Supplement because the individual packets contain undeclared milk and soy allergens.

    Product
    Z Pro 25 High Protein Supplement Net. Wt. 1.5 oz. - Chocolate Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0892-2013·2013-03-13

    Ad-Tech Macro Micro Subdural Electrodes Recalled for Sharp Edges

    Ad-Tech Medical Instrument Corporation is recalling Macro Micro Subdural Electrodes because they may have sharp edges or fracture, posing a risk of injury to brain tissue.

    Product
    Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of elect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1051-2013·2013-03-13

    Deep Foods Recalls Dry Garlic Chutney for Unapproved Dye

    Deep Foods Inc. is recalling 4-ounce jars of Dry Garlic Chutney because the product contains unapproved dyes, Rhodamine B and Basic Violet 10.

    Product
    Deep Best Quality Dry Garlic Chutney (Thechaa); Net Wt. 4 OZ.; UPC 011433111201; Deep Foods, Inc. Union, NJ 07083
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0907-2013·2013-03-13

    Siemens ARTISTE syngo RT Therapist software recall for beam delivery error

    Siemens is recalling 5 ARTISTE digital linear accelerators due to a software defect that may cause repeated delivery of radiation beams.

    Product
    SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1046-2013·2013-03-13

    Tortilleria Provincia Yellow Corn Tortillas Recalled for Unlabeled Dye

    Tortilleria Provincia is recalling yellow corn tortillas because they contain FD&C Yellow #5, which is not listed on the ingredient label.

    Product
    Yellow Corn Tortillas in 5 lb clear flexible plastic bags with green and yellow printing. Tortilleria Provincia 1200 B Clay Street Bowling Green, KY 42101
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0904-2013·2013-03-13

    Synthes Multi-Vector Distractor Recalled Due to Shear Pin Specification Issues

    Synthes USA is recalling 24 Multi-Vector Distractors because the sheer pin may not meet product specifications. The devices are used for mandibular bone lengthening.

    Product
    Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0912-2013·2013-03-13

    Atricure Max1 Isolator Transpolar Pen Recalled for Incorrect Labeling

    Atricure Inc. is recalling five Max1 Isolator Transpolar Pens due to incorrect Instructions for Use labeling.

    Product
    Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-181-2013·2013-03-13

    Bristol Myers Squibb Recalls Abilify Tablets Due to Manufacturing Error

    Bristol Myers Squibb is recalling specific Abilify 30 mg tablets because rejected material was inadvertently shipped. The affected product was distributed in LA, TN, and CA.

    Product
    ABILIFY — ABILIFY (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-190-2013·2013-03-13

    Actavis Recalls Amphetamine Extended-Release Capsules for Dissolution Failure

    Actavis Elizabeth LLC is recalling 9,264 bottles of amphetamine extended-release capsules because the product failed to meet dissolution specifications.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0910-2013·2013-03-13

    Bard Access Systems Recalls Dual Lumen Catheters Due to Wrong Introducer Size

    Bard Access Systems is recalling specific lots of Hickman and Leonard catheters because the kits included the wrong size introducer.

    Product
    Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0902-2013·2013-03-13

    Salyer Prn Biomedical Recalls Century Console Base Units

    Salyer Prn Biomedical is recalling 9 Century Console Base units because the addition of a UPS Battery Backup did not comply with FDA premarket notification regulations.

    Product
    Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0915-2013·2013-03-13

    Steris Recalls Amsco Steam Sterilizers Due to Erroneous Alarm Activation

    Steris Corporation is recalling Amsco C and Amsco 400 steam sterilizers because control board defects cause erroneous alarms that lock up the devices.

    Product
    AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0909-2013·2013-03-13

    Bard Access Systems Recalls Hickman and Leonard Catheters Due to Wrong Introducer Size

    Bard Access Systems is recalling specific lots of Hickman and Leonard catheters because the kits included the wrong size introducer.

    Product
    Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0914-2013·2013-03-13

    Churchill Medical Recalls Lifeguard Infusion Sets Due to Labeling Error

    Churchill Medical Systems is recalling 2,340 Lifeguard Infusion Sets because the labels incorrectly identify the needle gauge and item number.

    Product
    Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0905-2013·2013-03-13

    Synthes Multi-Vector Distractor Recalled for Non-Conforming Shear Pin

    Synthes USA is recalling 18 Multi-Vector Distractors because the shear pin may not meet product specifications.

    Product
    Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0913-2013·2013-03-13

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Software Recall

    Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers due to a software data storage limitation that may prevent saving of certain sample results.

    Product
    Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0903-2013·2013-03-13

    Synthes Multi-Vector Distractor Body Recalled for Manufacturing Defect

    Synthes USA HQ, Inc. is recalling two units of the Multi-Vector Distractor Body because the sheer pin may not meet product specifications.

    Product
    Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-182-2013·2013-03-13

    Glenmark Recalls Montelukast Sodium Tablets Due to Chemical Contamination

    Glenmark Generics Inc. is recalling Montelukast Sodium Tablets, 10 mg, due to trace levels of chemical contaminants causing off-odors.

    Product
    Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0917-2013·2013-03-13

    ConMed Linvatec Recalls D3000I Surgical Drive Systems Due to Incorrect Symbology

    ConMed Linvatec is recalling 23 D3000I Advantage Drive Systems because the membrane switch panel contains incorrect symbology, violating IEC60606-01 standards.

    Product
    D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0911-2013·2013-03-13

    BD Vacutainer Plus Plasma Separator Tubes Recalled for Deformed Reservoirs

    Becton Dickinson is recalling BD Vacutainer Plus Plasma Separator Tubes due to deformed tube reservoirs reported in two customer complaints.

    Product
    BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for speci
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-185-2013·2013-03-13

    Aaron Industries Recalls Walgreens Wal-Tussin CF Max Due to Precipitate

    Aaron Industries is recalling 6,108 bottles of Walgreens Wal-Tussin CF Max because a white substance, confirmed as the active ingredient guaifenesin, was observed in some bottles.

    Product
    Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-186-2013·2013-03-13

    Rite Aid Tussin Cough Syrup Recalled for Precipitate Presence

    Aaron Industries is recalling Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF due to the presence of a white precipitate.

    Product
    Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0916-2013·2013-03-13

    Linvatec Recalls D3000 Advantage Drive Systems Due to Incorrect Panel Symbology

    Linvatec Corp. is recalling 31 D3000 Advantage Drive Systems because the front panel contains incorrect symbology, violating IEC60606-01 standards.

    Product
    D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-189-2013·2013-03-13

    VersaPharm Ethambutol Tablets Recalled for Discoloration

    West-ward Pharmaceutical Corp. is recalling VersaPharm Ethambutol Tablets USP 400 mg because the tablet cores may be discolored.

    Product
    VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11 Manufactured for: VersaPharm Incorporated Marietta, GA
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-188-2013·2013-03-13

    Aaron Industries Recalls Wal-Mart Equate Tussin CF Due to Precipitate

    Aaron Industries is recalling Wal-Mart Equate Tussin CF bottles containing a white precipitate. The substance is confirmed as guaifenesin, an active ingredient.

    Product
    Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-187-2013·2013-03-13

    Aaron Industries Recalls Select Brand Cough Control CF Max Due to Precipitate

    Aaron Industries Inc is recalling Select Brand Cough Control CF Max bottles due to the presence of a white precipitate, identified as the active ingredient guaifenesin.

    Product
    Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V090000·2013-03-12

    Crossroads RV Recalls 2013 Trailers Due to Fire Risk

    Crossroads RV is recalling 160 model year 2013 Redwood, Rushmore, and Elevation trailers because power converters may short circuit and cause a fire.

    Product
    CROSSROADS — CROSSROADS ELEVATION, REDWOOD, RUSHMORE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V088000·2013-03-12

    Terex Recalls 2012 Aerial Devices Due to Electrical Shock Risk

    Terex is recalling 2012 T292, TL, and NT Aerial Devices because a faulty inverter may fail to provide ground fault protection, posing an electrocution risk.

    Product
    TEREX — TEREX AERIAL DEVICES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13137·2013-03-12

    Soft Air USA Recalls Swiss Arms Air Rifle Due to Injury Hazard

    Soft Air USA is recalling Swiss Arms break-barrel air rifles sold at Sports Authority because they can discharge while the safety is engaged, posing a risk of injury.

    Product
    Break-Barrel Air Rifle
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V072000·2013-03-12

    Caterpillar Recalls CT660 Trucks for Missing Side Marker Lamps

    Caterpillar is recalling 2012 and 2014 CT660 heavy-duty trucks because missing side marker lamps or reflective tape reduce visibility and increase crash risk.

    Product
    CATERPILLAR — CATERPILLAR CT660
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V080000·2013-03-08

    GM Recalls 2011 Chevrolet Express CNG Conversions for Fire Risk

    General Motors is recalling 48 model year 2011 Chevrolet Express vans converted to compressed natural gas due to a potential vent pipe defect that could cause fire.

    Product
    CHEVROLET — CHEVROLET EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V089000·2013-03-07

    Terex Recalls Digger Derrick Trucks Due to Hydraulic Cylinder Defect

    Terex is recalling 1999-2012 Digger Derrick utility trucks because hydraulic cylinder shims may fail, causing the arm to collapse and injure operators.

    Product
    TEREX — TEREX DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V081000·2013-03-07

    Ford Recalls 2004-2007 Freestar and Mercury Monterey for Seat Defect

    Ford is recalling 2004-2007 Freestar and Mercury Monterey vehicles because the third-row seat may not latch properly due to corrosion, increasing injury risk in a rear-end crash.

    Product
    FORD — FORD, MERCURY FREESTAR, MONTEREY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13133·2013-03-07

    U.S. Divers Recalls Youth Snorkeling Masks Due to Laceration Hazard

    U.S. Divers is recalling Martinique LX Jr. youth snorkeling mask sets sold at Costco because notches in the tempered glass lens can break, posing a laceration hazard.

    Product
    Martinique LX Jr. Youth Snorkeling Mask Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V085000·2013-03-07

    Ford Recalls 2013 Focus, C-Max, and Escape for Child Lock Defect

    Ford is recalling 2013 Focus, C-Max, and Escape vehicles because the left rear door child lock may not engage properly, increasing the risk of injury to unrestrained children.

    Product
    FORD — FORD redundant C-MAX HYBRID, FOCUS, ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1029-2013·2013-03-06

    JS Pelmeni Ok Potato Dumplings Recalled for Undeclared Milk and Soy

    JS Pelmeni Ok is recalling 2 lb. frozen potato dumplings due to undeclared milk and soy ingredients discovered during a joint FDA and New York State inspection.

    Product
    Potato Dumplings, Net Weight 2 lb. (32 oz.), KEEP FROZEN, UPC 6 54368 10038 6, EST # A613069 --- JS Pelmeni OK - 667 Coney Island Ave., Brooklyn, NY 11218 - (718) 469-1490
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1025-2013·2013-03-06

    Teatulia Organic Lemongrass Ginger Green Tea Recalled for Salmonella Risk

    Teatulia is recalling In-House brand iced tea sold at Garbanzo Mediterranean Grill in Colorado due to potential Salmonella contamination.

    Product
    Sold as In-House brand iced tea: Garbanzo Mediterranean Grill Organic Lemongrass Ginger Green Tea, 3 oz. packages
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1011-2013·2013-03-06

    Giant Greens Recalls Brocco Sprouts Sandwich Blend Due to Listeria Risk

    Giant Greens, Inc. is recalling Brocco Sprouts Sandwich Blend due to potential contamination with Listeria monocytogenes. The product was distributed in the Pacific Northwest and British Columbia.

    Product
    Brocco Sprouts Sandwich Blend, packaged in a 4 oz. clamshell container, the UPC is 8 15098 00028 9. The product is labeled in parts: "***BROCCO SPROUTS SANDWICH BLEND***broccoli & clover sprouts***NET WT. 4.0 oz***DISTRIBUTED BY: BRASSICA PROTECTION PRODUCTS LLC, BALTIMORE, M
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1024-2013·2013-03-06

    Muffin Mam Strawberry Crème Cake Recalled for Undeclared Eggs

    The Muffin Mam, Inc is recalling 24oz Strawberry Crème Cakes because they contain undeclared eggs. The product was distributed in seven southeastern states.

    Product
    The Muffin Mam, Inc 24oz Strawberry Cr¿me Cake, UPC 7-60366-00986-3
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-1032-2013·2013-03-06

    GoldCoast Salads Blue Crab Spread Recalled for Listeria Contamination

    GoldCoast Salads is recalling Blue Crab Spread due to potential Listeria monocytogenes contamination. Consumers should discard the product or return it to the store.

    Product
    GoldCoast Salads Blue Crab Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1035-2013·2013-03-06

    GoldCoast Salads Smoked Salmon Spread Recalled for Listeria Risk

    GoldCoast Salads is recalling Smoked Salmon Spread due to potential Listeria monocytogenes contamination. Consumers in 11 states should discard the product.

    Product
    GoldCoast Salads Smoked Salmon Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1009-2013·2013-03-06

    Homestead Creamery Raw Milk Cheese Recalled for E. Coli Contamination

    Homestead Creamery is recalling Flory's Favorite raw milk cheese due to potential Shiga-toxin E. coli contamination. The product was distributed in Missouri and at a farmer's market.

    Product
    Homestead Creamery Artisan Cheese, Flory's Favorite, whole raw jersey milk, packaged in 1-lb or 1/2-lb block/plastic packs.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1007-2013·2013-03-06

    Zip International Recalls Uneviscerated Dry Salted Fish

    Zip International Group is recalling dry salted fish found to be uneviscerated during NYSDAM sampling. The product was distributed in New York.

    Product
    Bream Dry Salted Fish Net Wt.: about 14.2 oz Imported by Zip International Group LLC Product of Russia
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1033-2013·2013-03-06

    GoldCoast Salads Marine Lobster Spread Recalled for Listeria Contamination

    GoldCoast Salads is recalling Marine Lobster Spread due to potential Listeria monocytogenes contamination. Consumers should discard the product.

    Product
    GoldCoast Salads Marine Lobster Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-1016-2013·2013-03-06

    Giant Greens Recalls 3 Bean Munchies Sprouts for Listeria Risk

    Giant Greens, Inc. is recalling 3 Bean Munchies sprouts due to potential Listeria monocytogenes contamination. The product was sold in the Pacific Northwest and British Columbia.

    Product
    3 Bean Munchies sprouts is a mixture of Green Peas, Cow Peas, Red Lentils and Garbanzo Beans. Product is packaged in a 4 oz clamshell container and sold under the Sprouters Northwest brand. Product has UPC 8 15098 00204 7. The 3 Bean Munchies sprouts, 4 oz., is labeled in
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1034-2013·2013-03-06

    GoldCoast Salads Lobster & Shrimp Spread Recalled for Listeria Contamination

    GoldCoast Salads is recalling Lobster & Shrimp Spread due to potential Listeria monocytogenes contamination. Consumers should check for specific UPC codes and expiration dates.

    Product
    GoldCoast Salads Lobster & Shrimp Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-1030-2013·2013-03-06

    Js Pelmeni Ok Recalls Potato and Mushroom Dumplings for Undeclared Allergens

    Js Pelmeni Ok, Inc. is recalling frozen potato and mushroom dumplings because they contain undeclared milk and soy. The product was distributed in five states.

    Product
    Potato & Mushroom Dumplings, Net Weight 1 lb. (16 oz.), KEEP FROZEN, UPC 6 54368 10039 3 --- JS Pelmeni OK - EST # A615133 - 667 Coney Island Ave., Brooklyn, NY 11218 - (718) 469-1490
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1014-2013·2013-03-06

    Giant Greens Recalls Brocco Sprouts Due to Listeria Risk

    Giant Greens, Inc. is recalling Brocco sprouts due to potential Listeria monocytogenes contamination. Affected packages were distributed in five US states and British Columbia.

    Product
    Brocco sprouts is broccoli sprouts, packaged in a 4 oz. clamshell container or 85 gram package. The Brocco sprouts, 4oz., distributed BRASSICA, has UPC 8 15098 00025; The Brocco sprouts, 85 gram, produced for LIFE FORCE, has UPC 8 51042 00400 2. The Brocco sprouts, 4oz,
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1012-2013·2013-03-06

    Giant Greens Recalls Spicy Sprouts Due to Listeria Contamination Risk

    Giant Greens, Inc. is recalling Spicy Sprouts sold as Sprouters Northwest or LifeForce brands due to potential Listeria monocytogenes contamination.

    Product
    Spicy Sprouts, packaged in a 4 oz. clamshell container or 85 gram package. The product is sold under Sprouters Northwest or LifeForce brand. The Sprouters Northwest, 4 oz., has UPC is 8 15098 00202 3. The LifeForce, 85 gram, has UPC 8 51042 00401 9. The Sprouters Northw
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·13V082000·2013-03-06

    Kenworth T270 and T370 Trucks Recalled for Seat Belt Defect

    PACCAR is recalling 2014 Kenworth T270 and T370 trucks because a seat belt bracket may be mispositioned, increasing injury risk in a crash.

    Product
    KENWORTH — KENWORTH T370, T270
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1005-2013·2013-03-06

    Whole Foods Market Recalls Smoked Salmon for Listeria Risk

    Whole Foods Market is recalling specific lots of Wild Alaskan Sockeye Smoked Salmon due to potential Listeria monocytogenes contamination.

    Product
    Whole Foods Market Whole Catch Wild Alaskan Sockeye Smoked Salmon, Cold Smoked Sliced, Net Wt. 4 oz, Distributed by Whole Foods Market, Austin, TX 78703
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-1026-2013·2013-03-06

    QTrade Recalls Organic Lemon Grass Tea Due to Salmonella Risk

    QTrade Teas & Herbs is recalling Organic Lemon Grass Tea Bag Cut because it may be contaminated with Salmonella. The product was distributed nationwide and in Canada.

    Product
    Organic Lemon Grass Tea Bag Cut (TBC), Item#410. Packing Size: 25 kgs net double craft paper bags and double polyethylene bags each inner liner and repacked product packed in corrugated cartons with polyethylene inner liner. Organic Lemon Grass Tea Bag Cut (TBC) bulk sold in
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1010-2013·2013-03-06

    Giant Greens Recalls Clover Sprouts Due to Listeria Contamination Risk

    Giant Greens, Inc. is recalling Sprouters Northwest brand clover sprouts due to potential Listeria monocytogenes contamination. The product was distributed in the Pacific Northwest and British Columbia.

    Product
    Clover sprouts, product is packaged in a 4 oz or 5 oz. clamshell containers, and 1 lb. bag or 2 lb. tray. Product is sold under brand Sprouters Northwest. Clover Sprouts, 4oz container, has a UPC 8 15098 00201 6; Clover Sprouts, 5oz container, has a UPC 0 33383 70235 3; Clo
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-176-2013·2013-03-06

    Hospira Recalls 0.9% Sodium Chloride Irrigation Due to Sterility Concerns

    Hospira Inc. is recalling 56,854 units of 0.9% Sodium Chloride Irrigation, USP, 3000 mL, due to a potential leak from the administration port that compromises sterility.

    Product
    0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0896-2013·2013-03-06

    Orthofix Firebird Spinal Fixation System Rod Connectors Recalled for Cracking Risk

    Orthofix is recalling Firebird Spinal Fixation System rod connectors because a sub-component may crack during tightening.

    Product
    Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a lo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0887-2013·2013-03-06

    Aesculap Bipolar Generator Foot Pedal Recalled for Energy Failure

    Aesculap, Inc. is recalling 59 Bipolar Generator Foot Pedals because the bipolar energy did not stop after the pedal was released.

    Product
    Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-168-2013·2013-03-06

    Pacira Recalls Subpotent EXPAREL Bupivacaine Injectable Vials

    Pacira Pharmaceuticals is recalling 324 vials of EXPAREL (bupivacaine liposome injectable suspension) because the product is subpotent.

    Product
    EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1027-2013·2013-03-06

    GFS Lemon Pudding Recalled for Undeclared Milk Allergen

    Associated Milk Producers, Inc. is recalling GFS Lemon Pudding because the label fails to list milk, an ingredient present in the vanilla pudding component.

    Product
    GFS Lemon Pulling, Net Wt. 113 oz (7 lb 1 oz) 3.20 kg UPC 93901-10676. Distributed by Gordon Food Service, Grand Rapids, MI 49548.
    Category
    Food
    Distribution
    1 state

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