The Recall Desk

Archive

September 2013 recalls

530 recalls were announced in September 2013.

What the numbers show

Critical
15
Severe
184
High
234
Moderate
81
Low
16

Of the 530 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.

Which agencies issued them

301–400 of 530

  • HighFDA (Devices)·Z-2193-2013·2013-09-18

    CareFusion Recalls Thoracentesis Trays Due to Catheter Occlusion Risk

    CareFusion is recalling Thoracentesis and Safe-T Thoracentesis Trays because the included catheters may occlude, potentially delaying medical procedures and causing patient complications.

    Product
    *** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V451000·2013-09-18

    Nissan Recalls 2013 Armada and Titan for Brake Master Cylinder Defect

    Nissan is recalling 2013 Armada and Titan vehicles because a brake master cylinder defect may reduce front brake pressure, increasing the risk of a crash.

    Product
    NISSAN — NISSAN ARMADA, TITAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-978-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Methylcobalamin injections because FDA inspections found quality control issues that impacted sterility assurance.

    Product
    METHYLCOBALAMIN 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml and METHYLCOBALAMIN (PF) 1 MG/ML, 25 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2013·2013-09-18

    Siemens ADVIA Centaur Folate Reagent Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling 488 units of ADVIA Centaur Folate reagent due to calibration failures and quality control shifts.

    Product
    ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2191-2013·2013-09-18

    Lumenis Vision One Laser System Recalled for Unintended Laser Exposure

    Lumenis is recalling three Vision One Laser Systems due to a potential for unintended laser exposure to the user.

    Product
    Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2192-2013·2013-09-18

    BD Microtainer Quikheel Lancet Recalled for Failure to Retract

    Becton Dickinson is recalling BD Microtainer Quikheel Lancets because they may not retract after use, creating a risk of exposure to used sharps.

    Product
    BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2169-2013·2013-09-18

    Siemens ADVIA Centaur Folate Test Kits Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.

    Product
    ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states
  • HighNHTSA·13V443000·2013-09-18

    Craftsmen Custom Vehicles Recalled for Door Lock Jamming Hazard

    Craftsmen is recalling 2006-2013 custom vehicles with Fastec door locks that may jam, potentially trapping occupants inside the vehicle.

    Product
    CRAFTSMEN — CRAFTSMEN CUSTOM VEHICLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2013·2013-09-18

    Roche Recalls cobas 4800 HPV Test Kits Due to Formulation Error

    Roche Molecular Systems is recalling specific lots of cobas 4800 HPV test kits because a formulation error was identified during the manufacture of the Master Mix reagent.

    Product
    KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of Hum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1022-2013·2013-09-18

    University Compounding Pharmacy Recalls Testosterone Injection Due to Sterility Concerns

    University Compounding Pharmacy is voluntarily recalling Testosterone Cypionate/Testosterone Propionate Injection due to lack of assurance of sterility.

    Product
    Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2129-2013·2013-09-18

    Siemens Microscan rapID/S panels recalled for false susceptibility results

    Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.

    Product
    Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2013·2013-09-18

    B. Braun Outlook ES Pumps Recalled for Potential Drug Library Loss

    B. Braun Medical is recalling Outlook ES pumps because a software issue could cause the drug library to be lost, potentially leading to incorrect medication dosing.

    Product
    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2194-2013·2013-09-18

    Ormco Recalls Vector TAS 8mm Orthodontic Screws Due to Manufacturing Defect

    Ormco is voluntarily recalling one lot of Vector TAS 8mm orthodontic screws because some were machined undersized, which may cause the screws to break during use.

    Product
    Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1878-2013·2013-09-18

    Bubbles Baking Co. Recalls Coffee Cake Muffins for Undeclared Pecans

    Bubbles Baking Co. is recalling First Street Coffee Cake Muffins because they may contain undeclared pecan nuts. The recall covers 8,478 units distributed in California, Nevada, and Arizona.

    Product
    First Street Coffee Cake Muffins (S 45398) 4 count 14 oz. UPC 0 4151210848 8
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1879-2013·2013-09-18

    Reaction Nutrition Recalls Immune Support Supplement for Undeclared Colostrum Allergen

    Reaction Nutrition LLC is recalling 600 bottles of Clinical LIVE Immune Support capsules because they contain undeclared colostrum, a dairy allergen.

    Product
    Clinical LIVE Dietary Supplement Immune Support 694.325 mg 90 capsules Distributed by Reaction Nutrition, LLC., Carnegie, PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2183-2013·2013-09-18

    Monoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water

    FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water while labeled as saline or heparin.

    Product
    Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1877-2013·2013-09-18

    Stonyfield Organic Soy Yogurt Recalled for Coliform Levels

    Stonyfield Farm is recalling 1,680 cups of Organic O Soy Yogurt Strawberry due to coliform levels exceeding product specifications.

    Product
    Stonyfield Organic O Soy Yogurt Strawberry , 6 oz.cup, Refrigerated USPC code: 05215900603
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1036-2013·2013-09-18

    Qualitest Recalls K Effervescent Tablets Due to Labeling Mix-up

    Qualitest Pharmaceuticals is recalling 1,680 boxes of K Effervescent Tablets because they may be mislabeled as Potassium/Chloride Tablets.

    Product
    K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral Solution, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook,
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1037-2013·2013-09-18

    Qualitest Recalls Effervescent Potassium Chloride Tablets Due to Labeling Error

    Qualitest Pharmaceuticals is recalling 1,680 boxes of effervescent potassium chloride tablets because they may be mislabeled as a different potassium product.

    Product
    EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION, USP, FRUIT PUNCH FLAVOR, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2162-2013·2013-09-18

    Medical Indicators Recalls Tempa DOT Single-Use Clinical Thermometers

    Medical Indicators, Inc. is recalling Tempa DOT single-use clinical thermometers due to potential mislabeling. The recall affects 111,800 boxes distributed nationwide.

    Product
    Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2174-2013·2013-09-18

    Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Packaging Data Gaps

    Advanced Sterilization Products is recalling 1,923 STERRAD 100NX Cassettes because it lacks adequate data to support the packaging's leak indicator effectiveness for the full 15-month shelf life.

    Product
    STERRAD 100NX Cassettes, Product Code: 10144 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-2190-2013·2013-09-18

    HemoCue Glucose 201 Microcuvettes Recalled for Punctured Packaging

    HemoCue AB is recalling HemoCue Glucose 201 Microcuvettes because some single-pack pouches were found to be punctured during a complaint investigation.

    Product
    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2189-2013·2013-09-18

    Edwards Lifesciences Recalls FloTrac Sensor Due to Packaging Error

    Edwards Lifesciences is recalling 35 units of the FloTrac Sensor Model MHD85 because incorrect packaging configuration prevents validation of the product's sterility.

    Product
    "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2121-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Panels Recalled for Misreads

    Siemens is recalling Microscan Synergies Plus Negative panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative ba
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2165-2013·2013-09-18

    Baxa Vial Adapter Recall for Incorrect Expiry Date

    Baxter Healthcare is voluntarily recalling one lot of Baxa Vial Adapters due to an incorrect expiry date.

    Product
    Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.
    Category
    Medical Device
    Distribution
    1 state
  • SevereCPSC·13287·2013-09-17

    Waterlogic Recalls Chiller-Based Water Dispensers Due to Fire Hazard

    Waterlogic is recalling about 48,000 chiller-based water dispensers because the hot water tank can stop functioning and cause the machine to overheat, posing a fire hazard.

    Product
    Chiller-based water dispensers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V438000·2013-09-17

    Newmar Recalls 2012 Essex and King Aire Motor Homes for Brake Gauge Defect

    Newmar is recalling 2012 Essex and King Aire motor homes because air pressure gauges may be inaccurate, potentially hiding low air brake pressure and increasing crash risk.

    Product
    NEWMAR — NEWMAR ESSEX, KING AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V436000·2013-09-17

    Chalet RV Recalls Travel Trailers Due to Door Lock Jamming Risk

    Chalet RV is recalling 2006-2013 travel trailers and truck campers because a door lock defect could jam the deadbolt, trapping occupants inside.

    Product
    CHALET — CHALET, TAKENA ARROWHEAD, ALPINE, 1860, 1865
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13286·2013-09-17

    The Children's Place Recalls Footed Pajamas for Flammability Violation

    The Children's Place is recalling about 38,000 footed pajamas in the U.S. because they fail federal flammability standards, posing a burn hazard to children.

    Product
    Children's one-piece footed pajamas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V437000·2013-09-17

    Augusta RV Recalls 2013-2014 FLEX Models Due to Door Lock Defect

    Augusta RV is recalling 189 FLEX recreational vehicles because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    AUGUSTA — AUGUSTA FLEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V432000·2013-09-16

    Cowtown Sleepers Recalling Truck Sleepers Due to Door Lock Jamming Risk

    Cowtown Sleepers is recalling 2008-2013 truck sleepers because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    COWTOWN SLEEPERS — COWTOWN SLEEPERS TRUCK SLEEPERS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V433000·2013-09-16

    Hart Trailer Recalls Horse Trailers Due to Door Lock Jamming Risk

    Hart Trailer LLC is recalling 2006-2013 Medallion, Ultimate, and Cargo horse trailers because a door lock defect may jam, trapping occupants inside.

    Product
    HART — HART MEDALLION, ULTIMATE, CARGO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V423000·2013-09-13

    Arising Cargo Trailer Recall for Door Lock Jamming Hazard

    Arising Industries is recalling 2008-2013 cargo trailers because a door lock defect may jam the deadbolt, trapping occupants inside.

    Product
    ARISING — ARISING CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V424000·2013-09-13

    Coose Trailer Recalls Travel Trailers Due to Door Lock Jamming Risk

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

    Product
    COOSE TRAILER — COOSE TRAILER TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V426000·2013-09-13

    Pleasant Valley Travel Trailer Recall for Door Lock Jamming Hazard

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

    Product
    PLEASANT VALLEY — PLEASANT VALLEY TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V431000·2013-09-13

    Proline Travel Trailer Recall for Door Lock Jamming Hazard

    PROLine is recalling 2006-2013 travel trailers with Fastec door locks that may jam, potentially trapping occupants inside the vehicle.

    Product
    PROLINE — PROLINE TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V428000·2013-09-13

    Horton Cargo Trailer Recall for Door Lock Jamming Hazard

    Horton Vans is recalling 2006-2013 cargo trailers with Fastec door locks that may jam, potentially trapping occupants inside.

    Product
    HORTON — HORTON CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V427000·2013-09-13

    Adventurer Truck Campers Recalled for Door Lock Jamming Risk

    Adventurer LP is recalling 2009-2012 truck campers because a door lock defect may jam the deadbolt, trapping occupants inside the vehicle.

    Product
    ADVENTURER — ADVENTURER TRUCK CAMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V417000·2013-09-12

    Terex Recalls XT55 and XT60 Aerial Devices Due to Boom Cracks

    Terex is recalling 1997-2013 XT55 and XT60 aerial devices because cracks in the boom hinge may cause the platform to fall, risking injury.

    Product
    TEREX — TEREX XT55, XT60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V421000·2013-09-12

    Mitsubishi Fuso Trucks Recalled for Transmission Hose Clamp Defect

    Mitsubishi Fuso is recalling 2013-2014 FEC52, FEC72, FEC92, and FGB72 trucks because transmission oil cooler hoses may leak fluid, potentially causing the transmission to fail and increasing crash risk.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO FEC72, FEC52, FEC92, FGB72
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V419000·2013-09-12

    Lakota Recalls 2007 Travel Trailers Due to Door Lock Jamming Risk

    Lakota is recalling two 2007 travel trailer models because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    LAKOTA — LAKOTA 4HSLGN6, 3HSLBP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V422000·2013-09-12

    Champion Bus Recalls 598 Vehicles for Electrical Fire Risk

    Champion Bus is recalling 598 buses from 2009-2011 because voltage spikes may damage door header circuit boards, increasing the risk of a fire.

    Product
    CHAMPION — CHAMPION IC HIGH FLOOR, DEFENDER, EZ-TRANS, IC LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V418000·2013-09-12

    Cimarron Trailers Recall Livestock Trailers Due to Door Lock Defect

    Cimarron Trailers is recalling 2006-2012 livestock trailers because a door lock defect could jam the deadbolt, potentially trapping occupants inside.

    Product
    CIMARRON — CIMARRON SS, NS, LS, SW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-929-2013·2013-09-11

    FDA Recalls SexVoltz Herbal Supplement Containing Unapproved Tadalafil

    Beamonstar Products is recalling SexVoltz All Natural Herbal Supplement because it contains tadalafil, an unapproved drug ingredient.

    Product
    SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1865-2013·2013-09-11

    Zip International Recalls Baltic Sprats in Spicy Brine Due to Listeria Risk

    Zip International Group LLC is recalling Baltic Sprats in Spicy Brine because the product may be contaminated with Listeria monocytogenes.

    Product
    Baltic Sprats in Spicy Brine Net Wt. 15.8 oz. Prod. of Latvia Distributed by Zip International Group LLC 160 Raritan Center Parkway Unit #6 Edison NJ 08837 T 732-225-3600 UPC 4750217602547
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1866-2013·2013-09-11

    Kroger Cookie Dough Recalled for Undeclared Peanut Allergen

    Conagra is recalling Kroger Break 'N Bake Chocolate Chip Cookie Dough because peanut butter was present but not listed on the label.

    Product
    Kroger Break 'N Bake Chocolate Chip Cookie Dough, refrigerated dough, packaged in 16.0 oz. plastic package.
    Category
    Food
    Distribution
    26 states
  • CriticalFDA (Drugs)·D-930-2013·2013-09-11

    Velextra Herbal Supplement Recalled for Containing Unapproved Tadalafil

    Beamonstar Products is recalling Velextra All-Natural Herbal Supplement because it contains tadalafil, an unapproved drug ingredient.

    Product
    Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-928-2013·2013-09-11

    Teva Recalls CARBOplatin Injection Due to Sterility Assurance Failure

    Teva Pharmaceuticals is recalling CARBOplatin Injection because the required reduction of endotoxin was not met during annual revalidation of the vial washer.

    Product
    CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V416000·2013-09-11

    Yamaha Recalls 2011 Vino Classic Motorcycles for Brake Shoe Defect

    Yamaha is recalling 320 model year 2011 Vino Classic motorcycles because brake shoe linings may separate, reducing brake performance and increasing crash risk.

    Product
    YAMAHA — YAMAHA VINO CLASSIC (XC50A)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1871-2013·2013-09-11

    Dove Chocolate Fruit Collection Recalled for Incorrect Product Labeling

    Dove Chocolate Discoveries is recalling 18 oz boxes of Fruit Collection Dark Chocolate due to mislabeling. The boxes contain Cinnamon Dusted Dark Chocolate Almonds instead of the labeled fruit mix.

    Product
    Dove Chocolate Discoveries Fruit Collection Dark Chocolate - Covered Cranberries, Blueberries, Cherries Net Wt. 18 oz. Distributed by Dove Chocolate Discoveries, LLC A subsidiary of Mars, Incorporated Hackettstown, NJ 07840-1503 USA Item #3265D Each 18 oz box of mislabeled
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·13284·2013-09-11

    Hachette Recalls Children's Books Due to Choking and Laceration Hazards

    Hachette Book Group is recalling two children's board books because a metal rod with beads can detach, posing choking and laceration risks.

    Product
    Children's books titled "Count my Kisses, 1, 2, 3" and "Red, Green, Blue, I Love You"
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13282·2013-09-11

    L.L.Bean Recalls Boat Carts Due to Bursting Plastic Wheel Rims

    L.L.Bean is recalling Deluxe Packaway Boat Carts because plastic wheel rims can burst when tires are over-inflated, posing an injury risk.

    Product
    L.L.Bean Deluxe Packaway Boat Carts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1876-2013·2013-09-11

    ebA Multivitamin Recalled for Undeclared Milk Ingredients

    Saratoga Therapeutics is recalling ebA Multivitamin tablets because they contain milk components despite labeling stating they are free of milk.

    Product
    ebA*(TM) Multivitamin Supplement, 180 tablets in plastic bottles, Distributed by Saratoga Therapeutics, LLC, North Wales, PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1870-2013·2013-09-11

    H-E-B Jumbo Butterfly Shrimp Recalled for Unlabeled Coconut

    The Seafood Exchange of Florida is recalling H-E-B Jumbo Butterfly Shrimp because the product contains coconut, which is not listed on the label.

    Product
    H-E-B Jumbo Butterfly Shrimp-10.5 oz Box, 20 units per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2157-2013·2013-09-11

    Elekta Recalls DMLC IV-ERGO Beam Shaping Blocks for Radiation Therapy

    Elekta, Inc. is recalling 31 DMLC IV-ERGO beam shaping blocks used in radiation therapy due to potential clinical mistreatment from workflow errors or incorrect settings.

    Product
    DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V407000·2013-09-11

    BMW Recalls 2008-2010 Models for Taillight Electrical Contact Issues

    BMW is recalling 2008-2010 528i, 535i, 550i, and M5 vehicles because increased electrical resistance may cause rear lamp failure, reducing visibility to other drivers.

    Product
    BMW — BMW 535I, 550I, 528I, M5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1864-2013·2013-09-11

    Chocolate Covered Peanuts Mislabeled as Raisins in 4 oz Bags

    The Warrell Corporation is recalling chocolate covered peanuts mislabeled as raisins because the peanut allergen is not identified on the packaging.

    Product
    Chocolate covered raisinsin 4 oz flexible bags labeled in part "***Pennsylvania Dutch Candies***Chocolate Covered Raisins***NET WT 4 OZ (113g)***Packed for Pennsylvania Dutch Candies Camp Hill, PA***Manufactured In A Facility That Also Processes Peanuts***".
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2142-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 5 units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2013·2013-09-11

    MicroAire Steinmann Pins Recalled Due to Potential Sterility Compromise

    MicroAire Surgical Instruments is recalling Steinmann Pins because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.

    Product
    Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 162
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates

    Genzyme is recalling LeGoo Internal Vessel Occluder devices because they contain particulates (fibers). The recall affects 448 units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2153-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates

    Genzyme Corporation is recalling 37 units of LeGoo Internal Vessel Occluder 10mL because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2152-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Fiber Particulates

    Genzyme is recalling LeGoo Internal Vessel Occluder 5mL units because they contain fiber particulates. The recall covers 308 units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for tempo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers 660 units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the ves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme is recalling 110 units of LeGoo Endovascular Occlusion Gel 0.5 mL because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.

    Product
    LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2143-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme is recalling 45 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2013·2013-09-11

    DePuy Spine Recalls Confidence Spinal Cement System Kits

    DePuy Spine is recalling Confidence Spinal Cement System Kits because hydraulic pump leaks can cause loss of pressure during cement injection.

    Product
    CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyph
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-2150-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates

    Genzyme Corporation is recalling 652 units of LeGoo Internal Vessel Occluder because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling 181 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Fiber Particulates

    Genzyme Corporation is recalling 776 units of LeGoo Internal Vessel Occluder because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for tem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2013·2013-09-11

    DePuy Spine Recalls Confidence Spinal Cement System 5cc Kits

    DePuy Spine is recalling Confidence Spinal Cement System 5cc kits because hydraulic pump leaks can cause loss of pressure during injection.

    Product
    CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or ky
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-2144-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 250 units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. Le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1792-2013·2013-09-11

    Terrafina Pistachios Recalled for Potential Salmonella Contamination

    Terrafina is recalling five varieties of unsalted pistachios due to potential Salmonella contamination. The products were distributed in New York, New Jersey, and Florida.

    Product
    1) terrafina Natural Roasted Unsalted Pistachios, Net wt. 10 oz (283g) UPC 847938103201, 2) terrafina Natural California Unsalted Pistachios, Net wt. 13 oz (368g) UPC 847938063208, 3) terrafina Natural California Unsalted Pistachios, Net wt. 18 oz (510g) UPC 847938032051, 4) terr
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1791-2013·2013-09-11

    Terrafina Pistachios Recalled for Potential Salmonella Contamination

    Terrafina is recalling specific varieties of salted pistachios due to potential Salmonella contamination. The products were distributed in New York, New Jersey, and Florida.

    Product
    1) terrafina Natural Roasted Salted Pistachios, Net wt. 2.25 oz(63g) UPC 847938032112, 2) terrafina Natural Roasted Salted Pistachios, Net wt. 10 oz (283g) UPC 8497938103218, 3) terrafina Natural California Salted Pistachios, Net wt. 13 oz (368g) UPC 847938063215, 4) terrafina Na
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1863-2013·2013-09-11

    Tortillas Lupita Flour Tortillas Recalled for Undeclared Soy

    Tortillas Lupita Flour Tortillas are being recalled because they contain undeclared soy lecithin and soybean oil.

    Product
    Tortillas Lupita Flour Tortillas, Net Wt. 23oz, Manufactured By Tortilleria Lupita, 235 SW 25th St., Oklahoma City, OK 73109
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1867-2013·2013-09-11

    Thrive Foods Recalls 6 Grain Pancake Mix Due to Can Pressure Risks

    Thrive Foods is recalling 6 Grain Pancake Mix because ingredients react over time, increasing can pressure and the risk of injury when opened.

    Product
    THRIVE 6 Grain Pancake Mix; There are two unit sizes: (1) 4 lb. #10/gallon can (6.03x 7.02) (the "Gallon Cans"); and (2) 1.17 lb. Pull-Top Pantry Cans (4.01x 5.08) (the "Pantry Cans"). Both units are packaged in metal cans. The Pantry Can has a metal pull-top lid and the
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2013·2013-09-11

    Siemens Recalls ADVIA Chemistry A1c_3 Calibrators Due to Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry A1c_3 Calibrators because they cause a positive bias of up to 12% in HbA1c test results.

    Product
    ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates

    Genzyme Corporation is recalling 331 units of LeGoo Internal Vessel Occluder 2.5mL because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for tem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2141-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers 100 units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 220 units distributed worldwide.

    Product
    LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2140-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling 65 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers lots distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the ve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2159-2013·2013-09-11

    MicroAire Kirschner-Wire Recall Due to Defective Sterile Pouch Seals

    MicroAire Surgical Instruments is recalling Kirschner-Wires because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.

    Product
    Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2013·2013-09-11

    Stelkast Recalls Distal Femoral Augments Due to Sterility Breach

    Stelkast Co is recalling 11 units of SC2316 Distal Femoral Augments with Screws due to a breach of sterility in the packaging.

    Product
    SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2138-2013·2013-09-11

    Boston Scientific Recalls 4.0mm Flextome Cutting Balloon Devices

    Boston Scientific is recalling 4.0mm x 15mm Flextome Cutting Balloon devices because users may be unable to remove the protector cap.

    Product
    Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm F
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Food)·F-1874-2013·2013-09-11

    Justin's Recalls Maple Almond Butter Due to Metallic Fragments

    Justin's Nut Butter is voluntarily recalling specific lots of Maple Almond Butter and Chocolate Hazelnut Butter due to the presence of foreign metallic fragments.

    Product
    Maple Almond Butter 16 oz Jar (Unit USPC 894455000322, Case USPC 894455002135)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1868-2013·2013-09-11

    Potter's Crackers Recalled for Tree Nut Cross-Contamination

    Potters Fine Foods is recalling 109 packages of Classic White Crackers due to cross-contamination with a walnut-containing dough.

    Product
    Potter's Crackers, Classic White, Net Wt 5 ounces, UPC 6 80569 15877 2, Potters Fine Foods LLC, 100 S. Baldwin, Madison WI 53703., Ingredients, Wheat Flour, Milk, Butter, Cracked Wheat, Sugar, Crystal Salt, Baking Powder, Black Pepper. Allergen Information: wheat, dairy & tree n
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2146-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling 994 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the ve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1873-2013·2013-09-11

    Hawaii Fresh Sweet and Thai Basil Recalled for Pesticide Residues

    Crown Pacific International is recalling sweet and Thai basil due to a Hawaii cease and desist order for positive pesticide samples.

    Product
    Hawaii Fresh Sweet Basil Hawaii Fresh Thai Basil product of the USA Crown Pacific International, Inc. Hilo, HI
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2156-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel 2.5 mL because the product contains particulates (fibers). The recall covers 100 units distributed worldwide.

    Product
    LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2137-2013·2013-09-11

    Boston Scientific Recalls Small Peripheral Cutting Balloon Catheters

    Boston Scientific is recalling 4.0mm x 15mm Small Peripheral Cutting Balloon catheters because users may be unable to remove the protector cap from the device.

    Product
    Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1) 4.0
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Food)·F-1859-2013·2013-09-11

    Contoocook Creamery Recalls Salted Butter Due to Elevated Bacterial Counts

    Contoocook Creamery is recalling salted butter in 8oz tubs and 5-gallon pails due to elevated coliform and standard plate counts.

    Product
    Butter (salted). 8oz round clear plastic tub and 5 gallon pail. UPC Code 7 93573 09802 3.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2133-2013·2013-09-11

    DePuy Spine Recalls Confidence Spinal Cement System Due to Pump Leak

    DePuy Spine is recalling the Confidence Spinal Cement System 11CC Plus Kit because water leaks in the hydraulic pump cause pressure loss, preventing cement injection.

    Product
    CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplast
    Category
    Medical Device
    Distribution
    33 states

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