The Recall Desk

Archive

May 2013 recalls

607 recalls were announced in May 2013.

What the numbers show

Critical
23
Severe
197
High
166
Moderate
184
Low
37

Of the 607 recalls this month scored against our rubric, 4% are Critical, 32% are Severe.

Which agencies issued them

401–500 of 607

  • ModerateFDA (Devices)·Z-1271-2013·2013-05-15

    Baxter Recalls Non-DEHP Y-Type Catheter Extension Set Kits

    Baxter Healthcare is recalling 513,000 units of IV extension tubing kits because separating packages can compromise the sterile barrier.

    Product
    A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administrat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1248-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of Mercury Spinal System rods due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-317-2013·2013-05-15

    Physicians Total Care Recalls Plavix 75 mg Due to Moldy Odor

    Physicians Total Care is recalling specific bottles of Plavix 75 mg tablets due to a chemical contamination causing an uncharacteristic moldy odor.

    Product
    Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1260-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Straight Rods

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System Straight Rod due to a raw material issue. The affected devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1237-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1262-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1234-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed the wrong pre-vacuum steam sterilization temperature.

    Product
    Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30¿ Downward Bend At Proximal End. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1221-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1220-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling 147,921 irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1225-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling 147,921 reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1223-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1229-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1231-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1215-2013·2013-05-15

    Becton Dickinson Recalls Gonorrhea Test Kits Due to False Positives

    Becton Dickinson is recalling 77 BD ProbeTec Neisseria gonorrhoeae Qx Amplified DNA Assay Reagent Packs due to increased levels of false positives.

    Product
    BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson a
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1235-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1218-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1226-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1256-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of the Mercury Spinal System DIA 5.5 x 30mm Straight Rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-318-2013·2013-05-15

    Liothyronine Sodium Tablets Recalled for Failed Stability Testing

    L. Perrigo Co. is recalling Liothyronine Sodium Tablets, 5 mcg, because they failed 3-month stability testing specifications.

    Product
    Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1266-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1258-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Straight Rods

    Spinal Elements is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1250-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod due to a raw material issue.

    Product
    Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1254-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1246-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of Mercury Spinal System lordosed rods due to a raw material issue. The affected devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1249-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of the Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod due to a raw material issue.

    Product
    Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1265-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The affected devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1264-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1252-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of Mercury Spinal System Lordosed Rods due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1251-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of Mercury Spinal System rods due to a raw material issue. The affected products were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • SevereNHTSA·13V197000·2013-05-14

    Gulf Stream Motorhomes Recalled for Electrical Wiring Fire Risk

    Gulf Stream is recalling 2001 model year motorhomes because improperly secured electrical wiring may cause wear, heat, and potential fire or injury.

    Product
    GULF STREAM — GULF STREAM ULTRA SUPREME, CONQUEST, ULTRA, CAVALIER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V199000·2013-05-14

    Starcraft Allstar Buses Recalled for Wheelchair Lift Cable Fire Risk

    Starcraft is recalling 2006-2012 Allstar buses because a wheelchair lift cable may not clear the lift, potentially causing a short circuit and fire.

    Product
    STARCRAFT — STARCRAFT ALLSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V194000·2013-05-13

    Subaru Recalls 2013 Outback and Legacy for Steering Column Defect

    Subaru is recalling 2013 Outback and Legacy vehicles because the steering column shafts may disengage, causing loss of steering control.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V191000·2013-05-13

    New Heights Recalls Equipter RB4000 Dump Trailers for Brake Defect

    New Heights LLC is recalling Equipter RB4000 dump trailers manufactured in December 2011 because a defective hydraulic brake actuator could cause a loss of braking ability.

    Product
    SERVICE BRAKES, HYDRAULIC recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V196000·2013-05-13

    Maserati Recalls 2005-2008 Models for Rear Tie Rod Corrosion Risk

    Maserati is recalling 7,438 vehicles due to insufficient anti-corrosion material on rear tie rods, which may weaken and fail, increasing crash risk.

    Product
    MASERATI — MASERATI, ALFA ROMEO GRANTURISMO, QUATTROPORTE, 8C
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13189·2013-05-10

    Meijer Recalls Touch Point Baseboard Heaters Due to Fire Hazard

    Meijer is recalling Touch Point portable baseboard convection heaters because they can overheat and cause fires. Consumers should stop using the units and return them for a refund.

    Product
    Touch Point Portable Baseboard Convection Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V189000·2013-05-10

    Fleetwood Recalls 2013-2014 RVs Due to Power Awning Motor Defect

    Fleetwood RV is recalling 196 recreational vehicles because power awning motor screws may shear, causing the awning to unfurl unexpectedly and increasing crash risk.

    Product
    FLEETWOOD — FLEETWOOD STORM, SEARCHER COMMERCIAL, PROVIDENCE, MONTARA COMMERCIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V193000·2013-05-10

    Altec Recalls 2010-2011 AC35/38 Cranes Due to Jib Bracket Defect

    Altec is recalling 2010-2011 AC35/38 cranes because the jib attachment bracket may fail under load, posing an injury risk to nearby people.

    Product
    ALTEC — ALTEC AC35/38 CRANE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V188000·2013-05-09

    Magic Tilt Boat Trailer Hydraulic Brake Actuator Recall

    Magic Tilt is recalling boat trailers with defective hydraulic brake actuators that may fail, causing loss of braking ability and increasing crash risk.

    Product
    SERVICE BRAKES, HYDRAULIC recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V187000·2013-05-09

    KME Emergency Vehicles Recalled for Steering Column Grease Fitting Defect

    Kovatch is recalling specific KME emergency vehicles because a grease fitting in the steering column may tear the cover, potentially causing a loss of steering control.

    Product
    KME — KME PREDATOR SS, ARFF, PREDATOR, PANTHER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13187·2013-05-09

    Toro Recalls Z Master Riding Mowers Due to Fire Hazard

    Toro is recalling specific 2012 and 2013 Z Master Commercial riding mowers because the idler pulley can rub against the fuel tank, posing a fire hazard.

    Product
    Toro® Z Master® Riding Mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1369-2013·2013-05-08

    Farm Rich Pizza Dippers Recalled Due to E. coli O121 Contamination

    Rich Products Corp is recalling Farm Rich Better For You Pizza Dippers nationwide due to potential E. coli O121 contamination.

    Product
    Farm Rich Better For You Pizza Dippers-Pizza Dough made with Whole Wheat Flour and Stuffed with Mozzarella Cheese and Reduced Fat Mozzarella Cheese, Net Wt. 27-LBS (10 X 2.7-LB), UPC Code 00041322652782, Product Code 65278.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1371-2013·2013-05-08

    DZH Import Recalls Dried Mushrooms for Undeclared Sulfites

    DZH Import & Export Inc. is recalling two brands of dried mushrooms sold in New York City because they contain undeclared sulfites.

    Product
    Dried mushrooms sold under the following brand names: 1) CURIOSITY OF DASHAN brand DRIED MUSHROOM, N.W. 100G (3.5 OZ), UPC 6 939457 003484, Product of China --- Imported By: DZH Import & Export Inc. 70-21 51 Avenue, Woodside, NY 11377 Tel: 718-205-8312 Fax: 718-205-8146 --
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1170-2013·2013-05-08

    Hospira Recalls GemStar Infusion Pumps Due to Unexpected Shutdowns

    Hospira Inc. is recalling GemStar infusion pumps because they may shut off during use without warning, potentially interrupting patient medication delivery.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposab
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1370-2013·2013-05-08

    Farm Rich Pizza Dippers Recalled for Potential E. coli O121 Contamination

    Rich Products Corp is recalling Farm Rich Better For You Pizza Dippers nationwide due to potential E. coli O121 contamination.

    Product
    Farm Rich Better For You Pizza Dippers-Pizza Dough Stuffed with Reduced Fat Mozzarella Cheese, Net Wt 25-LBS (5 X 5-LB), UPC Code 10041322652338, Product Code 65233.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1189-2013·2013-05-08

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Therapy Failure Risk

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may fail to deliver defibrillation therapy in Manual Defib or AED mode.

    Product
    HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V182000·2013-05-08

    Spartan Motorhome Chassis Recall for Steering Bracket Cracking

    Spartan Motors is recalling 2006-2011 K2, K3, and MM motorhome chassis because steering brackets may crack and detach, causing loss of steering.

    Product
    SPARTAN — SPARTAN K3, K2, MM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1376-2013·2013-05-08

    Buffalo Trace Hot Barbeque Sauce Recalled for Missing Allergen Labels

    Buffalo Trace Distillery is recalling 16 fl. oz. jars of Hot Barbeque Sauce because the labels failed to list soy and anchovy allergens.

    Product
    BUFFALO TRACE HOT BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: [email protected] website: www.bu
    Category
    Food
    Distribution
    27 states
  • SevereNHTSA·13V185000·2013-05-08

    Temsa Recalls TS35C Coach Buses Due to Fuel Tank Leak Risk

    Temsa is recalling 172 model year 2011-2013 TS35C coach buses because a production error may cause the fuel tank to leak, posing a fire risk.

    Product
    TEMSA — TEMSA TS35C
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1159-2013·2013-05-08

    Hospira Recalls GemStar Infusion Pumps Due to Battery Data Loss

    Hospira Inc. is recalling GemStar infusion pumps because low battery levels can corrupt history logs and cause an error that prevents the device from being used.

    Product
    GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1169-2013·2013-05-08

    Hospira GemStar Infusion Pumps Recalled for Unintended Shutdowns

    Hospira Inc. is recalling GemStar infusion pumps because they may shut off during use without warning. The recall affects pumps distributed worldwide.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposab
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1160-2013·2013-05-08

    Hospira Recalls GemStar Infusion Pumps Due to Battery Data Loss

    Hospira is recalling GemStar infusion pumps because low battery levels can corrupt data and cause an error that prevents the device from being used.

    Product
    GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable bat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1373-2013·2013-05-08

    Buffalo Trace Bourbon Fudge Sauce Recalled for Missing Allergen Labeling

    Buffalo Trace Distillery is recalling 1,686 jars of Bourbon Fudge Sauce because the label failed to list milk and soy allergens.

    Product
    BUFFALO TRACE BOURBON FUDGE SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: [email protected]
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-1367-2013·2013-05-08

    Rich Products Recalls Mozzarella Bites for E. coli O121 Contamination

    Rich Products Corp is recalling Mozzarella Bites potentially contaminated with E. coli O121. The recall covers 820,577 cases distributed nationwide.

    Product
    Mozzarella Bites distributed under the following labels: Farm Rich Cheese In a Pizzeria Style Crust, Product Code 36450 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1; Product Code 37443 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1; Product Code 37433 Net Wt. 22-oz bag-UPC Code 0 4
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-311-2013·2013-05-08

    Axara Recalls Well at Walgreens Antacid Liquid Due to E. Coli Contamination

    Tarmac Products, Inc. is recalling specific lots of Well at Walgreens Regular Strength Antacid Liquid due to elevated microbial counts and E. Coli contamination.

    Product
    "Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-308-2013·2013-05-08

    Hospira Recalls Morphine Sulfate Injection Due to Sterility Concerns

    Hospira Inc. is recalling 26,100 vials of Morphine Sulfate Injection because a loose crimp on the vial cap may compromise sterility.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1185-2013·2013-05-08

    Medi-Trace Pediatric Defibrillation Electrodes Recalled for Arcing Risk

    FDA is recalling Medi-Trace Cadence Pediatric Defibrillation Electrodes because arcing or sparking may damage the leadwire, preventing the device from delivering appropriate energy to patients.

    Product
    Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-309-2013·2013-05-08

    Hospira Recalls Diazepam Injection Vials Due to Sterility Concerns

    Hospira Inc. is recalling 172,350 vials of Diazepam Injection due to a loose crimp on the fliptop vial that compromises sterility assurance.

    Product
    DIAZEPAM — DIAZEPAM (DIAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V184000·2013-05-08

    Autocar Recalls 2005-2013 Trucks Due to Missing Air Brake Drain Valves

    Autocar is recalling 82 model year 2005-2013 ACX, WX, and WXLL trucks because their air brake systems lack required drain valves, potentially reducing brake performance.

    Product
    AUTOCAR — AUTOCAR WXLL, WX, ACX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1192-2013·2013-05-08

    Owens & Minor Recalls MediChoice OB/GYN Applicators Due to Rayon Defect

    Owens & Minor is withdrawing MediChoice OB/GYN applicators because the rayon tip may loosen or unravel during use.

    Product
    MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13185·2013-05-08

    Surly Pugsley Bicycle Forks Recalled Due to Fall Hazard

    Surly Bikes is recalling Pugsley bicycle forks that can bend above the disc brake mount, posing a fall hazard to riders.

    Product
    Surly Pugsley Bicycle Forks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1375-2013·2013-05-08

    Buffalo Trace Barbecue Sauce Recalled for Missing Soy and Anchovy Allergens

    Buffalo Trace Distillery is recalling 16 fl. oz. jars of Original Flavor Barbecue Sauce because the label failed to list soy and anchovy allergens.

    Product
    BUFFALO TRACE ORIGINAL FLAVOR BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: [email protected] web
    Category
    Food
    Distribution
    27 states
  • HighNHTSA·13V183000·2013-05-08

    Autocar Recalls 2012-2013 ACX Trucks for Windshield Wiper Defect

    Autocar is recalling 797 model year 2012-2013 ACX trucks because insufficient welds may cause windshield wiper arms to fail, hindering driver vision.

    Product
    AUTOCAR — AUTOCAR ACX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2013·2013-05-08

    Siemens Medical Solutions Recalls RT Therapist Software for Safety Issues

    Siemens Medical Solutions is recalling RT Therapist software versions 4.2.108 to fix multiple safety-related issues on linear accelerator systems.

    Product
    Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2013·2013-05-08

    Vital Images Recalls Vitrea CT Brain Perfusion Software Due to User Confusion

    Vital Images is recalling Vitrea CT Brain Perfusion software versions 6.0 and above due to potential user confusion when viewing scans from wide coverage shuttle acquisition techniques.

    Product
    Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1000-2013·2013-05-08

    Trophy CareStream Dental CS 2200 X-ray System Recall for Bent Connector

    Trophy Sas is recalling CareStream Dental CS 2200 X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.

    Product
    CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1368-2013·2013-05-08

    Rich Products Recalls Farm Rich Pizza Dough Stuffed with Mozzarella

    Rich Products Corp is recalling Farm Rich Stuffed Crust Pizza Dippers potentially contaminated with E. coli O121. The recall covers nationwide distribution.

    Product
    Farm Rich Stuffed Crust Pizza Dippers-Pizza Dough Stuffed with Mozzarella Cheese, Net Wt. 27-LBS (10 X 2.7-LB), UPC Code 10041322652659, Product Code 65265; Net Wt. 25-LB (1 X 25-LB) UPC Code 10041322652680, Product Code 65268.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2013·2013-05-08

    GE Healthcare Recalls CT Scanners Due to Heat Exchanger Bolt Defect

    GE Healthcare is recalling 166 CT scanners because improperly torqued heat exchanger bolts may cause parts to detach and spill oil.

    Product
    GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1366-2013·2013-05-08

    Wegmans Recalls Roasted Red Pepper Dip Due to Missing Allergen Labeling

    Wegmans is recalling Roasted Red Pepper Dip because some containers have incorrect labels that fail to list milk and eggs.

    Product
    Wegmans Food You Feel Good About Roasted Red Pepper Dip, Net Wt 8 oz. (227g) Product is packaged in plastic containers, 12 containers per case. UPC: 77890 23286 with a best-by date of 5/17/2013. Commodity Code: 23286, Item #: DIPWG23286
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1191-2013·2013-05-08

    Medtronic Recalls DBS Therapy Kits Due to Potential Lead Damage

    Medtronic is recalling DBS Therapy for Dystonia Kits because the provided lead cap may damage the lead connector, potentially compromising the device.

    Product
    Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2013·2013-05-08

    Medi-Trace Cadence Adult Defibrillation Electrodes Recalled for Thermal Damage Risk

    FDA is recalling Medi-Trace Cadence Adult Defibrillation Electrodes because arcing or sparking may cause thermal damage to the leadwire, potentially preventing the device from delivering appropriate energy to patients.

    Product
    Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1372-2013·2013-05-08

    Buffalo Trace Bourbon Flavored Caramel Sauce Recalled for Missing Milk Allergen Label

    Buffalo Trace Distillery is recalling 1,504 jars of Bourbon Flavored Caramel Sauce because the label failed to list milk as an allergen.

    Product
    BUFFALO TRACE BOURBON FLAVORED CARAMEL SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: greatboubon@buffa
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-1190-2013·2013-05-08

    Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Damage Risk

    Medtronic is recalling 30,000 Deep Brain Stimulation lead kits worldwide because the provided lead cap may damage the lead connector during use.

    Product
    Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dyston
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1183-2013·2013-05-08

    B. Braun Recalls Diacap Ultra Dialysis Fluid Filters Due to Moisture Loss

    B. Braun Medical is recalling 1,580 Diacap Ultra Dialysis Fluid Filters because residual moisture may reduce over time, lowering membrane permeability.

    Product
    Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2013·2013-05-08

    Stryker AxSOS Drill Bit Recalled Due to Incorrect Scale

    Stryker Orthopaedics is recalling AxSOS Calibrated Drill Bits because an incorrect scale may cause surgeons to select screws that are 10mm longer than intended.

    Product
    Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm Drill
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2013·2013-05-08

    Newport Medical Instruments Recalls HT70 Ventilator Power Pac Batteries

    Newport Medical Instruments is voluntarily recalling HT70 and HT70 Plus ventilator Power Pac batteries because they may cause the ventilator to alarm and switch to backup power sooner than expected.

    Product
    Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of indi
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Food)·F-1374-2013·2013-05-08

    Buffalo Trace Meat Marinade Recalled for Missing Wheat and Anchovy Allergens

    Buffalo Trace Distillery is recalling 12 fl. oz. meat marinade bottles because the label failed to list wheat and anchovy allergens.

    Product
    BUFFALO TRACE MARINADE FOR MEAT Net Wt. 12 fl. oz. PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: [email protected] website: www.buffalotr
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-1177-2013·2013-05-08

    Maquet SERVO-i Ventilator Battery Modules Recalled for Shorter Run Time

    Maquet is recalling SERVO-i ventilator battery modules because some units have shorter battery run times than expected.

    Product
    Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respirat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1180-2013·2013-05-08

    Advanced Sterilization Products Recalls STERRAD CYCLESURE 24 Biological Indicators

    Advanced Sterilization Products is recalling STERRAD CYCLESURE 24 Biological Indicators because the company lacks adequate data to support the entire labeled shelf-life.

    Product
    STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-304-2013·2013-05-08

    Warner Chilcott Recalls Jevantique Tablets Due to Chemical Contamination

    Warner Chilcott is recalling Jevantique tablets because 2-phenylphenol was found in the product. The contamination resulted from migration from the cardboard cartons used for packaging.

    Product
    Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Distributed by Watson Pharma, Inc. Corona, CA 92880.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1094-2013·2013-05-08

    Trophy CareStream Dental X-ray System Recalled for Bent Connector Defect

    Trophy Sas is recalling CareStream Dental Kodak 2100 Intraoral X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.

    Product
    CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1095-2013·2013-05-08

    Trophy CareStream Dental Kodak 2200 Intraoral X-ray System Recall

    Trophy Sas is recalling CareStream Dental Kodak 2200 Intraoral X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.

    Product
    CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-306-2013·2013-05-08

    Donnatal Extentabs Recalled for Incorrect Expiration Date Labeling

    West-ward Pharmaceutical is recalling 1,258 bottles of Donnatal Extentabs because the bottles are labeled with an expiration date of April 2015 instead of the correct April 2013.

    Product
    Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1212-2013·2013-05-08

    GE Healthcare Recalls Optima MR430s MRI Scanners Due to Coolant Leak Risk

    GE Healthcare is recalling 81 Optima MR430s MRI scanners because coolant supply lines may leak liquid onto the floor, creating a slippery surface and fall hazard.

    Product
    Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1187-2013·2013-05-08

    Masimo Recalls Rad-8 Pulse Oximeters Due to Unintended Power-Off Defect

    Masimo is recalling 42,908 Rad-8 pulse oximeters worldwide because a small percentage of devices may power off unexpectedly when the patient cable is moved.

    Product
    Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-307-2013·2013-05-08

    Benjamins Infants Gripe Mixture Recalled for Manufacturing Violations

    Carib Import & Export is recalling 480 bottles of Benjamins Infants Gripe Mixture because FDA inspections found it was not manufactured under current good manufacturing practices.

    Product
    Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co. Ltd
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1355-2013·2013-05-08

    Vanilla Eskimo Dessert Bar Recalled for Undeclared Food Dye

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz Vanilla Eskimo Dessert Bars because the product contains undeclared FD&C Yellow #6.

    Product
    Vanilla Eskimo Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 in clear flexible package, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, yellow 5 UPC Code 8 94163 00230 4
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1354-2013·2013-05-08

    Mango Dessert Bar Recalled for Undeclared Food Dyes

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Mango Dessert Bars because they contain undeclared FD&C Yellow # 6 and Blue # 1.

    Product
    Mango Dessert Bar, 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic. Ingredients: water, sugar, mango, partially hydrogenated palm kernel oil, nonfat milk solids UPC Code 8 94163 00220 5
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1365-2013·2013-05-08

    Vanilla Dessert Bar Recalled for Undeclared FD&C Yellow # 6

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Vanilla Dessert Bars because the product contains undeclared FD&C Yellow # 6. The bars were sold in retail stores in Michigan and Indiana.

    Product
    Vanilla Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 packaged in clear flexible plastic, ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, corn syrup, whey powder, raisins....red 40, yellow 5 UPC Code 8 94163 00220 5
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1211-2013·2013-05-08

    GE Healthcare Recalls MSK Extreme MR Scanners Due to Coolant Leak Risk

    GE Healthcare is recalling 70 MSK Extreme MR Scanners because coolant supply lines may leak liquid onto the floor, creating a slippery surface and fall hazard.

    Product
    MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Food)·F-1353-2013·2013-05-08

    Pineapple Fruit Bar Recalled for Undeclared Food Dyes

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz Pineapple Fruit Bars because the packaging fails to list FD&C Yellow #6 and Red #40.

    Product
    Pineapple Fruit Bar, 4 oz. Undeclared FD&C Yellow # 6 and Red # 40 packaged in clear flexible plastic ingredients: water, pineapple, sugar, citric acid, yellow 5 UPC Code 8 94163 00210 6
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1356-2013·2013-05-08

    Spicy Mango Dessert Bar Recalled for Undeclared Food Dyes

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Spicy Mango Dessert Bars because the product contains undeclared FD&C Yellow # 6 and Blue # 1.

    Product
    Spicy Mango Dessert Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic, ingredients: water, mango, sugar, lime juice, salt, citric acid, chili powder, yellow 5, red 40
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1357-2013·2013-05-08

    Spicy Cucumber Fruit Bar Recalled for Undeclared Food Dyes

    Paleteria Y Neveria La Rosita, LLC is recalling Spicy Cucumber Fruit Bars because they contain undeclared FD&C Yellow # 6 and Blue # 1.

    Product
    Spicy Cucumber Fruit Bar , 4 oz. Undeclared FD&C Yellow # 6 and Blue # 1 in clear flexible plastic ingredients: water, cucumber, sugar, orange juice, lime juice, salt, citric acid, chili powder, yellow 5, red 40 UPC Code 8 94163 00210 6
    Category
    Food
    Distribution
    2 states

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