The Recall Desk

Archive

December 2012 recalls

411 recalls were announced in December 2012.

What the numbers show

Critical
23
Severe
79
High
198
Moderate
100
Low
11

Of the 411 recalls this month scored against our rubric, 6% are Critical, 19% are Severe.

301–400 of 411

  • ModerateFDA (Devices)·Z-0469-2013·2012-12-12

    Stryker Orthopaedics Recalls Mismarked Femoral Offset Bushing Instruments

    Stryker Howmedica Osteonics Corp. is recalling 7 units of non-sterile Femoral Offset Bushing Triathlon Revision Instruments due to incorrect or missing rotational markings.

    Product
    Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-087-2013·2012-12-12

    Genentech Recalls Nutropin AQ NuSpin 20 Due to Defective Delivery System

    Genentech is recalling 10,306 syringes of Nutropin AQ NuSpin 20 because the dose knob may spin slowly, causing delayed injection delivery.

    Product
    Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0454-2013·2012-12-12

    Stryker Neptune 2 Rover Recall Due to Castor Binding Defect

    Stryker is recalling Neptune 2 Rover waste management systems because a castor design defect can cause the unit to bind, potentially leading to operator back pain.

    Product
    Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid was
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-076-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab 0.088 mg. Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 3.8 million Thyro-Tab 0.088 mg. tablets because they do not meet in-process specification requirements.

    Product
    Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0480-2013·2012-12-12

    Siemens Mobilette Mira Mobile X-ray System Recalled for Image Loss Risk

    Siemens Medical Solutions USA is recalling 21 Mobilette Mira mobile x-ray systems due to a risk of lost images during examination.

    Product
    Siemens Mobilette Mira, intended use as Mobile x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-088-2013·2012-12-12

    Genentech Recalls Nutropin AQ NuSpin 10 Due to Defective Delivery System

    Genentech is recalling 12,791 syringes of Nutropin AQ NuSpin 10 because the dose knob may spin slowly, causing delayed injection delivery.

    Product
    Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-077-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to Manufacturing Deviations

    Lloyd Inc. of Iowa is recalling specific lots of Levothroid tablets because they failed to meet in-process specification requirements.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-081-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements.

    Product
    Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-084-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab 0.300 mg Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 1,902,957 Thyro-Tab 0.300 mg tablets because they do not meet in-process specification requirements.

    Product
    Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-073-2013·2012-12-12

    Ferring Recalls Novarel Injection Due to Missing Anaphylaxis Warning

    Ferring Pharmaceuticals is recalling Novarel (Chorionic Gonadotropin) vials because the package insert is missing a warning about anaphylaxis.

    Product
    Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manufactured by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada. NDC # 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-086-2013·2012-12-12

    Taro Recalls Fluorouracil Topical Cream Due to Stability Issues

    Taro Pharmaceuticals is recalling Fluorouracil Topical Cream 5% because out-of-specification results were found in retain samples.

    Product
    FLUOROURACIL — FLUOROURACIL (FLUOROURACIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-079-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements due to cGMP deviations.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-083-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling specific lots of Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-082-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 3.7 million Thyro-Tab tablets because they do not meet in-process specification requirements and involve cGMP deviations.

    Product
    Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-074-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Manufacturing Deviations

    Lloyd Inc. of Iowa is recalling 1.9 million Thyro-Tab tablets because they failed to meet in-process specification requirements.

    Product
    Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-085-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets because they do not meet in-process specification requirements.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-075-2013·2012-12-12

    Lloyd Inc. Recalls Levothroid Tablets Due to Manufacturing Deviations

    Lloyd Inc. of Iowa is recalling specific bottles of Levothroid tablets because they failed to meet in-process specification requirements during manufacturing.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0463-2013·2012-12-12

    Sekisui Spectrolyse PAI-1 Assay Recalled for Lower Absorbance Values

    Sekisui Diagnostics is recalling Spectrolyse PAI-1 kits because they produce lower than expected absorbance values, which reduces the standard curve slope.

    Product
    Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2013·2012-12-12

    Siemens syngo.plaza Radiological Image Processing System Software Update Recall

    Siemens Medical Solutions USA, Inc. is recalling 15 syngo.plaza systems to address unintended software behavior that may affect system performance.

    Product
    Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-078-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 3.8 million Thyro-Tab 0.112 mg tablets because they do not meet in-process specification requirements.

    Product
    Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0470-2013·2012-12-12

    Stryker Tibial Offset Bushing Recall Due to Incorrect Markings

    Stryker Howmedica Osteonics is recalling 8 Tibial Offset Bushings because rotational reference numbers were marked incorrectly or missing.

    Product
    Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-080-2013·2012-12-12

    Lloyd Inc. Recalls Thyro-Tab 0.125 mg. Tablets Due to cGMP Deviations

    Lloyd Inc. of Iowa is recalling 1,924,174 tablets of Thyro-Tab 0.125 mg. (Lot #HB27811) because the product does not meet in-process specification requirements.

    Product
    Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0742-2013·2012-12-12

    Blue Diamond Almond Breeze Almond Milk Recalled for Undeclared Cocoa

    HP Hood LLC is recalling Blue Diamond Almond Breeze Almond Milk because it may contain undeclared cocoa and evaporated cane juice.

    Product
    Blue Diamond Almond Breeze Almond milk Half Gallon (1.89 L) Paper Carton UPC: 4157005618
    Category
    Food
    Distribution
    8 states
  • SevereNHTSA·12V576000·2012-12-11

    Daimler Recalls 2007 Sterling 360 Trucks for Fuel Line Fire Risk

    Daimler Trucks North America is recalling 2007 Sterling 360 trucks because fuel lines may crack or flare nuts may be loose, creating a fire hazard.

    Product
    STERLING — STERLING 360
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V573000·2012-12-11

    Honda Recalls 2003-2006 Vehicles for Ignition Switch Interlock Defect

    Honda is recalling specific 2003-2006 Pilot, Odyssey, and Acura MDX vehicles because a deformed ignition switch lever may allow the vehicle to roll away if the key is removed without shifting to park.

    Product
    HONDA — HONDA, ACURA ODYSSEY, MDX, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V574000·2012-12-11

    Thor Motor Coach Recalls 727 RVs for Cruise Control Defect

    Thor Motor Coach is recalling 727 recreational vehicles because loose diode jumpers may prevent cruise control from disengaging or brake lights from illuminating.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH TUSCANY, ULTRASPORT, MONTECITO, PALAZZO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13063·2012-12-11

    Wing Enterprises Recalls Switch-it Stepladders Due to Fall Hazard

    Wing Enterprises is recalling Switch-it stepladders sold at Home Depot because the inner rails can separate, causing users to fall and sustain injuries.

    Product
    Stepladder and Stepstool Combination
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12V572000·2012-12-11

    Daimler Recalls Thomas Built Buses Due to Fan Pulley Fatigue Risk

    Daimler Trucks North America is recalling 2011-2013 Thomas Built Buses equipped with specific Cummins diesel engines because a fan pulley can fail, causing engine overheating and potential vehicle disablement.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V570000·2012-12-11

    Thomas Built School Buses Recalled for Engine Fan Pulley Defect

    Daimler Trucks North America is recalling 2011-2013 Thomas Built school buses equipped with specific Cummins diesel engines due to a fan pulley defect that can cause engine overheating and vehicle disablement.

    Product
    THOMAS BUILT — THOMAS BUILT, THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13064·2012-12-11

    Fu San Machinery Recalls Low Lead Ball Valves Due to Fire Hazards

    Fu San Machinery is recalling approximately 163,000 low lead ball valves installed in flammable gas lines because they can crack and leak gas, posing fire and explosion risks.

    Product
    Low Lead Ball Valve/Shut-Off Gas Valves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V577000·2012-12-10

    Champion Transit Buses Recalled for Cruise Control and Brake Light Defect

    Champion Bus is recalling 49 transit buses from 2011-2013 because loose connectors may prevent cruise control from disengaging or brake lights from illuminating.

    Product
    CHAMPION — CHAMPION CX380, CX300, 3035RE, CX340
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V580000·2012-12-10

    Glaval Transit Buses Recalled for Wheelchair Lift Cable Fire Risk

    Glaval is recalling 2007-2012 transit buses because a wheelchair lift cable may cause a short circuit and fire.

    Product
    GLAVAL — GLAVAL, GLAVAL BUS SPORT, TITAN, TITAN II, UNIVERSAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V579000·2012-12-10

    Spartan Emergency Chassis Recalled for Wiper Motor Shaft Defect

    Spartan Chassis is recalling 2012-2013 emergency rescue chassis cabs because wiper motor and arm shafts have different sized splines, which may cause windshield wipers to become inoperative.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR, FORCE, METROSTAR-X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V571000·2012-12-07

    Jaguar Recalls 2013 XF Vehicles Due to Fuel Pump Shutdown Risk

    Jaguar is recalling 2013 XF vehicles because electronic modules may shut down the fuel pump, causing the engine to stall and increasing crash risk.

    Product
    JAGUAR — JAGUAR XF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V569000·2012-12-07

    Coach and Equipment Recalls Phoenix and Metro-Lite Transit Buses

    Coach and Equipment is recalling 2006-2012 Phoenix and 2007/2009 Metro-Lite transit buses because a wheelchair lift cable may cause a short circuit and fire.

    Product
    COACH & EQUIPMENT — COACH & EQUIPMENT PHOENIX, METRO-LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V567000·2012-12-07

    Hyundai Recalls 2012 Veloster Vehicles Due to Parking Brake Binding

    Hyundai is recalling 2012 Veloster vehicles with manual transmissions because parking brake components may bind, potentially causing the vehicle to move unintentionally.

    Product
    HYUNDAI — HYUNDAI VELOSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V568000·2012-12-07

    Hyundai Recalls 2012 Veloster Vehicles Due to Sunroof Defect

    Hyundai is recalling 2012 Veloster vehicles with panoramic sunroofs because the glass assembly may be weakened, posing a risk of breakage while driving.

    Product
    HYUNDAI — HYUNDAI VELOSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13061·2012-12-06

    Dream On Me Recalls Baby Bath Seats Due to Drowning Hazard

    Dream On Me is recalling approximately 50,000 baby bath seats because they can tip over, posing a drowning risk to infants.

    Product
    Dream On Me Bath Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V566000·2012-12-06

    Winnebago and Itasca Motorhomes Recalled for Electrical Connector Defect

    Winnebago is recalling 2010-2013 Itasca and Winnebago motorhomes because loose electrical connectors may prevent brake lights from working or cruise control from disengaging.

    Product
    ITASCA — ITASCA, WINNEBAGO MERIDIAN, ELLIPSE, TOUR, JOURNEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V563000·2012-12-06

    Land Rover Recalls 2012 LR2 and Evoque for Brake Caliper Bolts

    Jaguar Land Rover is recalling 2012 LR2 and Range Rover Evoque vehicles because rear brake caliper bolts may be insufficiently torqued, posing a crash risk.

    Product
    LAND ROVER — LAND ROVER LR2, RANGE ROVER EVOQUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13059·2012-12-06

    Ridgid Pneumatic Nailers Recalled Due to Laceration Hazard

    One World Technologies is recalling Ridgid pneumatic nailers sold at Home Depot because the trigger assembly can malfunction and discharge fasteners, posing an injury risk.

    Product
    RIDGID Coil Roofing Nailer and RIDGID Clipped Head Framing Nailer
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12V565000·2012-12-06

    Spartan Recalls 2013 Motorhome Chassis Due to Brake Hose Damage Risk

    Spartan Chassis is recalling 2013 K2, K3, and MM motorhome chassis because front brake hoses or ABS sensor cables may be damaged by the swaybar, potentially increasing stopping distances or disabling ABS.

    Product
    SPARTAN — SPARTAN K3, K2, MM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V564000·2012-12-06

    Prevost Recalls 2011-2012 X3-45 Coach Buses Due to Fire Suppression Defect

    Prevost is recalling 87 model year 2011-2012 X3-45 coach buses because high engine temperatures may cause the fire suppression system to release prematurely, potentially preventing it from operating during a fire.

    Product
    PREVOST — PREVOST X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13710·2012-12-06

    Grandin Road Recalls Metal Chairs Due to Fall Hazard

    Grandin Road is recalling about 2,200 metal chairs because the back legs can bend when a person leans back, posing a fall and injury hazard.

    Product
    Metal Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0737-2013·2012-12-05

    Nestle Recalls Nesquik Chocolate Powder Due to Salmonella Risk

    Nestle is recalling specific lots of Nesquik Chocolate Powder because ingredients may be contaminated with Salmonella.

    Product
    Nesquik Chocolate Powder, 1) 6x40.7oz, UPC 0 28000 68230 9. 2) 12x21.8oz, UPC 0 28000 68090 9. 3) 12x10.9oz, UPC 0 28000 67990 3.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0735-2013·2012-12-05

    Kroger Ice Cream Recalled for Potential Pecan Allergen Contamination

    Kroger is recalling French Vanilla Magnifique Ice Cream because it may contain pecans, posing a severe allergic reaction risk to sensitive individuals.

    Product
    Kroger Deluxe French Vanilla Magnifique Ice Cream, 48 FL OZ laminated carton. INGREDIENTS: MILK, CREAM, SUGAR***CONTAINS: MILK, EGGS DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202***800-632-6900 or www.kroger.com.
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Devices)·Z-0161-2013·2012-12-05

    Medpro Elastomeric Infusion Pump Recalled for Higher Flow Rate

    First Medical Source LLC is recalling 500 units of Medpro Elastomeric Infusion Pumps because they may deliver medication at a higher flow rate than specified, risking over-administration.

    Product
    Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0740-2013·2012-12-05

    United Dairy Farms Ice Cream Recalled for Potential Salmonella Contamination

    United Dairy Farmers Inc is recalling Oatmeal Cookie Overload Ice Cream because it may contain salmonella. The product was distributed in Ohio, Indiana, Kentucky, and Michigan.

    Product
    United Dairy Farms brand Oatmeal Cookie Overload Ice Cream 3 gallon, corrugated square
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0439-2013·2012-12-05

    Cooper Surgical RUMI Arch Uterine Manipulator Handle Recalled for Steel Rod Protrusion

    Cooper Surgical is recalling RUMI Arch handles because excessive pressure may cause an internal steel rod to protrude through the shaft.

    Product
    Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-070-2013·2012-12-05

    Ranbaxy Recalls Atorvastatin Calcium Tablets Due to Glass Particulates

    Ranbaxy Inc. is recalling certain lots of Atorvastatin Calcium tablets because they may contain small glass particulates.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0435-2013·2012-12-05

    Terumo Advanced Perfusion System 1 Recalled for Total Loss of Functionality

    Terumo is recalling 1,647 Advanced Perfusion System 1 units because they may shut down completely, stopping pumps and failing to activate battery backup.

    Product
    100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0436-2013·2012-12-05

    Terumo Advanced Perfusion System 1 Recalled for Power Loss

    Terumo is recalling Advanced Perfusion System 1 units that may lose power and shut down during use, causing pumps to stop.

    Product
    220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-068-2013·2012-12-05

    GlaxoSmithKline Recalls Arranon Injection Due to Potential Impurities

    GlaxoSmithKline is recalling specific lots of Arranon (nelarabine) Injection because drug-related impurities may exceed specification limits.

    Product
    Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-063-2013·2012-12-05

    Samantha Lynn Recalls Reumofan Plus Tablets for Undeclared Ingredients

    Samantha Lynn, Inc. is recalling Reumofan Plus Tablets because they contain undeclared drug ingredients, making them unapproved drugs.

    Product
    Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0438-2013·2012-12-05

    Extremity Medical Recalls IO FiX X-Post Reamer Due to Intraoperative Breakage

    Extremity Medical LLC is recalling 156 units of the IO FiX X-Post Reamer after reports of the device breaking during surgery.

    Product
    IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
    Category
    Medical Device
    Distribution
    22 states
  • SevereFDA (Food)·F-0732-2013·2012-12-05

    Bolthouse Farms Carrot Chips Recalled Due to Salmonella Contamination

    Bolthouse Farms is recalling Carrot Chips after random sampling by the North Carolina Department of Agriculture found Salmonella. The product was distributed in the US and Canada.

    Product
    Bolthouse Farms Carrot Chips (Croustilles Aux Carottes). No Preservatives. Product of the U.S.A. Net Wt. 16 oz (1 lb) 454 b poids net. UPC 71464 17209 Product was also packed under brand names of Safeway Farms, UPC 21130 70217 and Farm Stand (private label for SuperValue).
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0731-2013·2012-12-05

    Murray's Waffle Cone Dip Recalled for Undeclared Milk and Soybean Oil

    CSM Bakery Products NA is recalling Murray's Waffle Cone Dip due to undeclared milk and soybean oil allergens caused by mislabeling.

    Product
    Murray's WAFFLE CONE DIP, NET WEIGHT - 7 lb 8 oz (3.40 kg), Product Item Code 835462, Bar code 0 06847 66003 2. The product is packaged in # 10 cans, 3 cans per case.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-072-2013·2012-12-05

    Ranbaxy Recalls Atorvastatin Calcium Tablets Due to Glass Particulates

    Ranbaxy Inc. is recalling specific lots of Atorvastatin Calcium tablets because they may contain small glass particulates.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0728-2013·2012-12-05

    Mercer's Ice Cream Recalled for Undeclared Soy Allergen

    Quality Dairy Farms Inc. is recalling Mercer's Ice Cream Cookies 'N Cream because the product contains soy lecithin but the label only lists lecithin.

    Product
    Mercer's Ice Cream Cookies 'N Cream, Half Gallon (1.89 Liter), UPC 036667 200392
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0729-2013·2012-12-05

    Mercer's Ice Cream Recalled for Undeclared Soy Lecithin

    Quality Dairy Farms Inc. is recalling Mercer's Ice Cream Cream N' Coffee Fudge because the product contains soy lecithin, which was not explicitly listed on the ingredient statement.

    Product
    Mercer's Ice Cream Cream N' Coffee Fudge, Half Gallon, (1.89 Liter), UPC 074513 003513
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0443-2013·2012-12-05

    Parks Medical Electronics Recalls Vascular Blood Flow Machines Due to Connection Error

    Parks Medical Electronics is recalling 349 vascular blood flow machines after two incidents where an air supply tube was connected to a patient's IV instead of a blood pressure cuff.

    Product
    Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0727-2013·2012-12-05

    Mercer's Ice Cream Recalled for Undeclared Soy Allergen

    Quality Dairy Farms Inc. is recalling Mercer's Ice Cream Old Fashioned Cookie Dough because the product contains soy lecithin, which was not explicitly listed on the ingredient statement.

    Product
    Mercer's Ice Cream Old Fashioned Cookie Dough, Half Gallon, (1.89 Liter), UPC 036667 200231
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0441-2013·2012-12-05

    Medtronic Recalls Vertex Max Drill Tubes Due to Threading Defect

    Medtronic is recalling 12 Vertex Max Drill Tubes due to a defect in the internal threading used for component setup.

    Product
    The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0726-2013·2012-12-05

    BumbleBar Recalls Gluten Free Cafe Chocolate Sesame Bars Due to Salmonella Risk

    BumbleBar, Inc. is recalling Gluten Free Cafe Chocolate Sesame Bars because they contain roasted peanuts from Sunland Inc. that may be contaminated with Salmonella.

    Product
    Gluten Free Cafe Chocolate Sesame Bar. The Retail Carton has a UPC 70795-03450 and the Individual Bar has a UPC 70795-03550. The product is labeled in parts: "***Chocolate Sesame Bars With Flax Seeds & Roasted Peanuts***gluten free cafe***NET WT .95 OZ (27g); myglutenfreecafe
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0736-2013·2012-12-05

    Chicken of the Sea Tuna Recalled for Undeclared Soy Allergen

    Chicken of the Sea is recalling Solid White Tuna in Water because the label fails to declare soy, a major food allergen.

    Product
    Chicken of the Sea Solid White Tuna in Water, 7 oz., 48 cans per case (case: 6 sets of multi-unit packs of 8 cans each), UPC 4800000097, case UPC 4800076127.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0734-2013·2012-12-05

    Ground Hot Pepper Chillies Recalled for Salmonella Contamination Risk

    Ernimich, Inc. is recalling 36 cases of Ground Hot Pepper Chillies due to potential Salmonella contamination. The product was distributed in Virginia, Maryland, and Washington, D.C.

    Product
    Ground Hot Pepper Chillies, 5 oz. plastic jars, 24 jars/case; jars labeled in part ***Imported and distributed by Nina International Inc., P.O. Box 2176, Hyattsville, MD 20784***Product of Ghana***
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0739-2013·2012-12-05

    Whole Foods Recalls Wedding Cookies for Undeclared Pecans

    Whole Foods Market is recalling Wedding Cookies sold in five states because they contain undeclared pecans, a major allergen.

    Product
    Wedding Cookies (Baked Fresh In-Store), Whole Foods Market, sold by the pound.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0724-2013·2012-12-05

    Jimmy Dean French Toast & Sausage Sandwich Recalled for Undeclared Allergens

    Hillshire Brands is recalling Jimmy Dean French Toast & Sausage Sandwiches because the back label lists ingredients for a different product, omitting egg and soy.

    Product
    Jimmy Dean French Toast & Sausage Sandwich, Net Wt 3.9 oz (110g); a food service individually butcher paper wrapped, fully cooked frozen sandwich; 12 sandwiches per 2.74 lb case; UPC 54500 51434
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0725-2013·2012-12-05

    BumbleBar Gluten Free Cafe Cinnamon Sesame Bar Recalled for Salmonella Risk

    BumbleBar, Inc. is recalling Gluten Free Cafe Cinnamon Sesame Bars due to potential Salmonella contamination from roasted peanuts.

    Product
    Gluten Free Cafe Cinnamon Sesame Bar. The Retail Carton has a UPC 70795-03451 and the Individual Bar has a UPC 70795-03551. The product is labeled in parts: "***Cinnamon Sesame Bars With Flax Seeds & Roasted Peanuts***gluten free cafe***NET WT .95 OZ (27g); myglutenfreecafe.c
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2013·2012-12-05

    Zimmer Recalls NexGen Knee Components Due to Manufacturing Cleaning Defects

    Zimmer is recalling specific lots of NexGen knee components because they were processed outside validated cleaning parameters, potentially leaving residual particulate.

    Product
    NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic a
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Drugs)·D-071-2013·2012-12-05

    Ranbaxy Recalls Atorvastatin Calcium Tablets Due to Glass Particulates

    Ranbaxy Inc. is recalling certain lots of Atorvastatin Calcium tablets because they may contain small glass particulates.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2013·2012-12-05

    Cooper Surgical Recalls Advincula Arch Uterine Manipulator Handles

    Cooper Surgical is recalling Advincula Arch handles because the internal steel rod may protrude through the shaft, posing a risk of injury during surgery.

    Product
    Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2013·2012-12-05

    GE Healthcare Recalls Mobile X-Ray Units Due to Software Issue

    GE Healthcare is recalling Optima XR200amx and XR22Oamx mobile X-ray units due to a software issue on the interface.

    Product
    GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0733-2013·2012-12-05

    Nestle Coffee-Mate Creamer Recalled for Manufacturing Error Causing Acidity

    Nestle Professional is recalling specific lots of Coffee-Mate Original Liquid Creamer Singles due to a manufacturing error that causes the product to become acidic.

    Product
    Nestle Coffee-Mate Coffee Creamer, Original Flavor, packaged as 3/8 fl oz single serve tubs.50 single serve tubs are packaged in a self dispensing fiberboard box. Four fiberboard boxes are packaged in a case.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0448-2013·2012-12-05

    GE Healthcare Recalls Mobile X-ray Systems Due to Software Issue

    GE Healthcare is recalling Optima XR220amx and XR200amx mobile X-ray systems due to a software issue on the product interface.

    Product
    GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-067-2013·2012-12-05

    Boehringer Ingelheim Recalls Pradaxa 75 mg Capsules Due to Defective Containers

    Boehringer Ingelheim is recalling 8,381 bottles of Pradaxa 75 mg capsules because defective containers may allow moisture to enter, potentially impairing product quality.

    Product
    Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0449-2013·2012-12-05

    GE Healthcare Recalls Mobile X-Ray Systems Due to Software Issue

    GE Healthcare is recalling Optima XR220amx and XR200amx mobile X-ray systems due to a software issue on the interface.

    Product
    GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-069-2013·2012-12-05

    Procter & Gamble Recalls Vicks NyQuil Due to Illegible Labeling

    Procter & Gamble is recalling 17,532 bottles of Vicks NyQuil Cold & Flu because portions of the dosing directions and warnings are obscured.

    Product
    Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0446-2013·2012-12-05

    Iradimed Recalls MRidium Series 1000 MR Infusion Sets Due to Specification Defect

    Iradimed Corporation is recalling 719 MRidium Series 1000 MR Infusion Sets because a section of the device does not meet specifications.

    Product
    The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0442-2013·2012-12-05

    Biomet Echo Hip Stems Recalled Due to Incorrect Size Etching

    Biomet, Inc. is recalling four Echo Bi-Metric hip stems because the etching on the 11mm stems incorrectly indicated they were 13mm stems.

    Product
    Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0451-2013·2012-12-05

    Kimberly-Clark Patient Warming System Model 1000 Recalled for False Alarms

    Kimberly-Clark is recalling 400 Model 1000 Patient Warming System Control Units because the Error 85 alarm occasionally triggered inappropriately.

    Product
    Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0444-2013·2012-12-05

    Metrex Research Recalls Pinnacle Cure Sleeves Due to Labeling Error

    Metrex Research is recalling Pinnacle Cure Sleeves because boxes labeled for 11mm light guides contain sleeves for 7mm or 8mm guides.

    Product
    Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0445-2013·2012-12-05

    Diamedix Recalls Is-anti-Sm Test Kits Due to Control Failure

    Diamedix Corporation is recalling 65 Is-anti-Sm Test Kits because the positive control recovered high out of specification.

    Product
    The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-065-2013·2012-12-05

    GlaxoSmithKline Recalls Advair HFA Inhalers Due to Particle Size Issues

    GlaxoSmithKline is recalling 18,676 units of Advair HFA inhalers because they failed to meet particle size distribution specifications.

    Product
    ADVAIR HFA — ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-064-2013·2012-12-05

    GlaxoSmithKline Recalls Advair HFA Inhalers Due to Particle Size Issues

    GlaxoSmithKline is recalling specific lots of Advair HFA inhalers because they failed to meet particle size distribution specifications.

    Product
    ADVAIR HFA — ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE)
    Category
    Drug
    Distribution
    Distributed nationwide

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