The Recall Desk

Archive

June 2014 recalls

399 recalls were announced in June 2014.

What the numbers show

Critical
28
Severe
90
High
152
Moderate
113
Low
16

Of the 399 recalls this month scored against our rubric, 7% are Critical, 23% are Severe.

301–399 of 399

  • ModerateFDA (Devices)·Z-1705-2014·2014-06-11

    Spacelabs Ultraview SL Command Module Recalled for Software Anomaly

    Spacelabs Healthcare is recalling 64 Ultraview SL Command Modules because a software anomaly causes false positive temperature alarms.

    Product
    Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1692-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Issues

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile pouch holding the inflation assembly may have a weak seal or be open.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1687-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Defects

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile pouch holding the inflation assembly may have an open or weak seal.

    Product
    Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1698-2014·2014-06-11

    Leica Monoclonal Antibody Recalled for Reduced Functionality

    Leica Microsystems is recalling Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi because it does not function as intended up to the expiry date.

    Product
    Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1695-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Failure

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS 8" Circle because the sterile pouch holding the inflation assembly may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1697-2014·2014-06-11

    Integra Newdeal SURFIX Screws Recalled for Packaging Labeling Error

    Integra LifeSciences is recalling specific lots of SURFIX locking screws because some 22mm units were mislabeled as 30mm units.

    Product
    Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone frac
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1359-2014·2014-06-11

    CareFusion Recalls Surgical Scrub Brushes With Low Iodine Levels

    CareFusion is recalling surgical scrub brushes because the available iodine content is lower than stated on the label.

    Product
    CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1696-2014·2014-06-11

    Bard Ventralight ST Mesh Recalled for Potential Sterile Pouch Seal Defects

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile pouch holding the inflation assembly may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Pouch Seal Failure

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS due to potential pouch seal failures that could compromise sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1685-2014·2014-06-11

    Bard Composix LIP Mesh Recall Due to Potential Packaging Seal Defects

    Davol, Inc. is recalling specific lots of Bard Composix LIP Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1682-2014·2014-06-11

    Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Issues

    Davol, Inc. is recalling Composix LP hernia mesh because the sterile packaging may have weak seals, potentially compromising sterility.

    Product
    Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1710-2014·2014-06-11

    Leica CD15 Antibody Recalled for Reduced Function Before Expiration

    Leica Microsystems is recalling 145 units of CD15 antibody that may not function as intended before the expiration date due to age-related staining issues.

    Product
    Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1985-2014·2014-06-11

    Gavina Dark Whole Bean Coffee Recalled for Mislabeling as Decaffeinated

    F. Gavina & Sons Inc. is recalling 29 units of Gavina Northwest Blend Dark Whole Bean Coffee because it was mislabeled as decaffeinated.

    Product
    Gavina Northwest Blend Dark Whole Bean Bag Net Wt. 5lb, Product label reads in part "***085895***DECAF EUROPEAN BLEND 5LBS WHOLEBEAN BAG***"
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1674-2014·2014-06-11

    CryoLife Recalls BioGlue Surgical Adhesive Due to Albumin Component Failure

    CryoLife, Inc. is recalling 6,190 units of BioGlue Surgical Adhesive because the serum albumin component failed to meet internal shelf-life specifications.

    Product
    BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1720-2014·2014-06-11

    Small Bone Innovations Recalls Non-Sterile RingFIX Olive Wires

    Small Bone Innovations is recalling non-sterile RingFIX Olive Wires because they were packaged with the wrong internal component.

    Product
    SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1683-2014·2014-06-11

    Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Defects

    Davol, Inc. is recalling Composix LP with Echo PS hernia mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2009-2014·2014-06-11

    Rockman Skinless Peanuts Recalled for Mold and Mislabeling

    Rockman Company USA Inc. is recalling skinless peanuts due to mold contamination and mislabeling. The affected product was distributed in several US states.

    Product
    Rockman (Brand) Skinless Peanut, 12 oz. Description: blanched skinless peanut. Packaged in plastic pouch. 12oz/60bags/carton. Product labeling reads in part: "ROCKMAN***SKINLESS PEANUT 12 0Z (342G)***DISTRIBUTED BY: ROCKMAN (AUSTRALIA) PTY LTD.***AUSTRALIA***PRODUCT OF C
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-1988-2014·2014-06-11

    Prep Enterprises Recalls Captain Kratom and Related Products

    Prep Enterprises is recalling Captain Kratom, Arena Ethnobotanicals, and Kratom Pro products because they may contain Kratom.

    Product
    CAPTAIN KRATOM GOLD XL 30 Grams MAENG DA CAPSULES CAPTAIN KRATOM GOLD 15 GRAMS MAENG DA CAPSULES CAPTAIN KRATOM PREMIUM THAI POWDER 15 Grams CAPTAIN KRATOM PREMIUM BALI CAPSULES 15 Grams CAPTAIN VIETNAM KRATOM PREMIUM PLATINUM STRAIN 15 GRAMS CAPTAIN KRATOM PREMIUM THAI LEAF
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Food)·F-2007-2014·2014-06-11

    American Spoon Sour Cherry Preserves Recalled for Potential Mold Contamination

    American Spoon Foods is recalling 2,887 jars of Sour Cherry Preserves because they may contain mold. Consumers should check their jars and stop using them if they match the description.

    Product
    American Spoon¿ Sour Cherry PRESERVES Richer in Fruit (56 Brix) Made in Small Batches Net Wt. 9.5 oz/269g, glass jar INGREDIENTS: Red Tart Cherries, , Sugar, Lemon Juice, Pectin. ALLERGY INFORMATION: Manufactured in a facility that also processes soybeans, milk, eggs, fish, and t
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-1360-2014·2014-06-11

    CareFusion Recalls Surgical Scrub Brushes With Low Iodine Levels

    CareFusion is recalling surgical scrub brushes because the available iodine content is lower than stated on the label.

    Product
    CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1681-2014·2014-06-11

    Synthes XRL Medium Trial Central Body Recalled for Incorrect Dimension Etching

    Synthes, Inc. is recalling two lots of the Synthes XRL Medium Trial-Central Body device because they were incorrectly etched with the wrong height dimensions.

    Product
    Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MA
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1677-2014·2014-06-11

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System due to a software anomaly that may delay patient test results.

    Product
    enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to VI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1693-2014·2014-06-11

    Bard Ventralight ST Mesh Recall for Potential Sterility Compromise

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1691-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Defects

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS 6" Circle due to potential defects in the sterile inflation assembly pouch seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1689-2014·2014-06-11

    Bard Ventralight ST Mesh Recall for Potential Sterile Pouch Seal Issues

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile inflation assembly pouch may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1680-2014·2014-06-11

    Bacterin Elutia Wound Drains Recalled for Missing Dose Audits

    Bacterin International is recalling Elutia Hubless Coated Silicone Surgical Wound Drains because quarterly dose audits were omitted. The products were appropriately sterilized.

    Product
    Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1684-2014·2014-06-11

    Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Defects

    Davol, Inc. is recalling Composix LP hernia mesh because the sterile packaging may have weak seals, potentially compromising sterility.

    Product
    Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1995-2014·2014-06-11

    American Licorice Company Recalls Redvines Fruit Vines Bites for Labeling Error

    American Licorice Company is recalling Redvines Fruit Vines Bites because the packaging incorrectly lists the sodium content as 35g instead of 35mg.

    Product
    REDVINES FRUIT VINES Bites Strawberry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Facts: ***Sodium 35g***ALLERGEN INFORMATION: CONTAINS WHEAT***AMERICAN LICORICE COMPANY, UNION CITY, CA 94587 UPC 0 41364 82006 4
    Category
    Food
    Distribution
    9 states
  • LowFDA (Food)·F-1994-2014·2014-06-11

    American Licorice Company Recalls Redvines Fruit Vines Bites Due to Labeling Error

    American Licorice Company is recalling Redvines Fruit Vines Bites Cherry because the packaging incorrectly lists sodium content as 35g instead of 35mg.

    Product
    REDVINES FRUIT VINES Bites Cherry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Facts: ***Sodium 35g***ALLERGEN INFORMATION: CONTAINS WHEAT***AMERICAN LICORICE COMPANY, UNION CITY, CA 94587 UPC 0 41364 82001 9
    Category
    Food
    Distribution
    9 states
  • SevereNHTSA·14V310000·2014-06-10

    Hyundai Recalls Elantra Touring Vehicles Due to Headliner Bracket Hazard

    Hyundai is recalling 2010-2012 Elantra Touring vehicles because a headliner support bracket may become displaced during airbag deployment, posing a laceration risk.

    Product
    HYUNDAI — HYUNDAI ELANTRA TOURING
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V311000·2014-06-10

    Subaru Recalls Vehicles for Brake Line Corrosion Risk

    Subaru is recalling specific 2005-2014 models due to brake line corrosion from salt water, which may cause fluid leaks and increased stopping distances.

    Product
    SUBARU — SUBARU WRX STI, LEGACY, OUTBACK, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V379000·2014-06-10

    UTEC Aerial Trucks Recalled for Potential Exhaust Fire Risk

    Utility Truck Equipment Company is recalling certain 2010-2013 UTEC aerial trucks and Ford chassis due to a PTO oil leak that could ignite the exhaust thermal blanket.

    Product
    UTEC — UTEC, FORD UTLN46, UTLI41A, F-550 SD, F-350 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V382000·2014-06-10

    Ford Super Duty Chassis Recalled for PTO Oil Leak Fire Risk

    Somerset Welding & Steel is recalling 2009-2013 Ford F-350, F-450, and F-550 Super Duty chassis with specific PTO assemblies due to a fire risk from oil leaks.

    Product
    FORD — FORD F-550 SD, F-350 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14202·2014-06-10

    SCOTT Recalls Speedster Bicycles Due to Front Fork Breakage Hazard

    SCOTT is recalling 2014 Speedster and Contessa Speedster road bicycles because the front fork steerer tube can break, posing a fall hazard.

    Product
    2014 SCOTT® Speedster 30 and 40, and Contessa Speedster 25 and 35 road bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14203·2014-06-10

    Weil-McLain Recalls Ultra Series Boilers Due to Fire and Explosion Risk

    Weil-McLain is recalling approximately 7,900 Ultra Series gas-fired boilers in the U.S. because a manifold cap can crack and release gas, posing a risk of fire and explosion.

    Product
    Weil-McLain Ultra models 80, 105, 155 and 230 MBH Ultra Series Boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V370000·2014-06-09

    MCI Recalls 2014 Motor Coaches Due to Headlight Software Defect

    Motor Coach Industries is recalling 686 model year 2014 motor coaches because a software defect may cause headlights to turn off while driving, increasing crash risk.

    Product
    MCI — MCI D4505, D4000ISTV, D4005, D4000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V300000·2014-06-06

    GM Recalls 2012 Vehicles for Driver Air Bag Deployment Failure

    General Motors is recalling specific 2012 Buick Verano, Chevrolet Cruze, Sonic, and Camaro vehicles because the driver's air bag may fail to deploy in a crash.

    Product
    CHEVROLET — CHEVROLET, BUICK CRUZE, SONIC, CAMARO, VERANO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V299000·2014-06-06

    GM Recalls 2014 Chevrolet Corvettes for Airbag Deactivation Risk

    General Motors is recalling 2014 Chevrolet Corvettes because a module short circuit may disable airbags and seat belt pretensioners.

    Product
    CHEVROLET — CHEVROLET CORVETTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V337000·2014-06-06

    Micro Bird Recalls G5 School Buses Due to Propane Leak Risk

    Micro Bird is recalling 2011-2013 G5 school buses with Roush propane systems because a metal reaction may cause a fuel leak, increasing fire risk.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V298000·2014-06-06

    GM Recalls 2013 Buick Encore and Chevrolet Spark for Air Bag Defect

    General Motors is recalling specific 2013 Buick Encore and Chevrolet Spark vehicles because an improper weld may prevent the passenger air bag from deploying, increasing injury risk.

    Product
    CHEVROLET — CHEVROLET, BUICK SPARK, ENCORE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V301000·2014-06-06

    GM Recalls 2014-2015 Trucks and SUVs for Radio Software Defect

    General Motors is recalling specific 2014-2015 Chevrolet and GMC vehicles because a radio software defect may disable audible safety warnings for open doors and unbuckled seat belts.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO, TAHOE, SIERRA, SIERRA HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V305000·2014-06-05

    KTM Recalls 2014 690 Enduro R Motorcycles Due to Rear Brake Pedal Defect

    KTM is recalling 649 model year 2014 690 Enduro R motorcycles because the rear brake pedal mounting bolt may loosen, allowing the pedal to detach and increasing crash risk.

    Product
    KTM — KTM 690 ENDURO R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1969-2014·2014-06-04

    Miravalle Ground Annato Spice Recalled for Potential Salmonella Contamination

    Miravalle Foods is recalling 0.75oz bottles of Achiote Molido Ground Annato spice due to potential Salmonella contamination. The product was distributed in seven western states.

    Product
    Miravalle (brand) Achiote Molido Ground Annato (spice), 0.75oz.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-1354-2014·2014-06-04

    Teva Recalls ParaGard T 380A Intrauterine Contraceptives for Sterility Failure

    Teva Pharmaceuticals is recalling 47,890 units of ParaGard T 380A intrauterine contraceptives in New York and Kentucky due to a failed sterility test.

    Product
    ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
    Category
    Medical Device
    Distribution
    2 states
  • SevereNHTSA·14V296000·2014-06-04

    NABI Recalls 2012 31LFW Buses Due to Steering Column Weld Defect

    NABI is recalling 39 model year 2012 31LFW city transit buses because the steering column support bracket may not be properly welded, potentially causing steering failure.

    Product
    NABI — NABI 31LFW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V307000·2014-06-04

    Tactical Recalls Modified Ford F-350 and F-550 Trucks Due to Fire Risk

    Tactical Vehicle Outfitters is recalling modified 2010-2014 Ford F-350 and F-550 trucks because oil leaks from the PTO pressure switch may ignite the exhaust thermal blanket.

    Product
    FORD — FORD F-550 SD, F-350 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V293000·2014-06-04

    Chrysler Recalls 2014 Vehicles for Adaptive Cruise Control Acceleration Defect

    Chrysler is recalling 2014 Dodge Durango, Jeep Cherokee, and Grand Cherokee vehicles because the adaptive cruise control system may cause unintended continued acceleration after the driver releases the pedal.

    Product
    DODGE — DODGE, JEEP DURANGO, CHEROKEE, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V295000·2014-06-04

    Ameritrail Recalls 2011 Ranch King Trailers Due to Brake Actuator Defect

    Ameritrail is recalling specific 2011 Ranch King trailers because a defective hydraulic pump component may cause a loss of braking ability, increasing the risk of a crash.

    Product
    RANCH KING — RANCH KING GN36-25D42, MFDD36-242, GN40-21D42, GN24-21E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1976-2014·2014-06-04

    Asian Bakery Recalls Marquiz Cakes Due to Undeclared Allergens

    Asian Bakery is recalling Marquiz cakes due to undeclared milk, wheat, and soy lecithin. The cakes were sold in Portland, Oregon, and Vancouver, Washington.

    Product
    Marquiz cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 15.8 oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1977-2014·2014-06-04

    Asian Bakery Recalls Cakes Due to Undeclared Wheat and Soy Lecithin

    Asian Bakery is recalling Bells cake and Round 8 cake due to undeclared wheat and soy lecithin. The products were sold in Portland, Oregon, and Vancouver, Washington.

    Product
    Bells cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 13oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code
    Category
    Food
    Distribution
    0 states
  • HighCPSC·14735·2014-06-04

    Lea Bunk Beds Recalled Due to Entrapment Hazard

    Lea Industries is recalling Covington and Hannah Collection bunk beds because incorrect assembly can create a space that traps young children.

    Product
    Lea Covington and Hannah Collection Bunk Beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2014·2014-06-04

    Abbott Recalls ARCHITECT Intact PTH Controls Due to Performance Shift

    Abbott is recalling ARCHITECT Intact PTH Controls because a performance shift may cause falsely elevated results on patient samples.

    Product
    ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminesc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1658-2014·2014-06-04

    Siemens ADVIA Centaur Vitamin D Test Recalled for Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling 40,266 ADVIA Centaur Systems VitD Total 100 test kits because samples containing fluorescein may interfere with the assay results.

    Product
    ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1669-2014·2014-06-04

    Synthes ProDisc-C Milling Bits Recalled Due to Breakage Risk

    Synthes, Inc. is recalling specific lots of ProDisc-C 2.0mm Milling Bits because they have an increased potential to break during use.

    Product
    Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling optio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1971-2014·2014-06-04

    Organic Traditions Dark Chocolate Sacha Inchi Seeds Recalled for Undeclared Milk

    Health Matters America Inc. is recalling Organic Traditions Dark Chocolate Sacha Inchi Seeds because the product contains undeclared milk, a major food allergen.

    Product
    Organic traditions DARK CHOCOLATE SACHA INCHI SEEDS***DAIRY & SUGAR FREE 80% DARK CHOCOLATE; Pack sizes: 3.5oz/100g, UPC 8 54260 00709 1; 5.3 oz (150g), UPC 8 54260 00718 3; 12kg bulk boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·14V304000·2014-06-04

    Van Hool Recalls TX40 and TX45 Motorcoaches for Seat Belt Defect

    Van Hool is recalling 2014-2015 TX40 and TX45 motorcoaches because the driver seat belt may not be properly secured, increasing injury risk in a crash.

    Product
    VAN HOOL — VAN HOOL TX40, TX45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1979-2014·2014-06-04

    Dr. Mercola Organic Cocoa Cassava Bars Recalled for Undeclared Milk

    Mercola Group is voluntarily recalling Dr. Mercola Organic Cocoa Cassava bars because they may contain undeclared milk protein.

    Product
    Organic Cocoa Cassava bars, 1.59 oz (45 g), individually packaged in foil pouches and sold under the Dr. Mercola brand. Sold at retail locations in display cases containing 12 bars per display case. 12 display cases are packaged in each master case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1970-2014·2014-06-04

    Organic Traditions Dark Chocolate Recalled for Undeclared Milk Allergen

    Health Matters America Inc. is recalling Organic Traditions Dark Chocolate Golden Berries because the product contains undeclared milk, a major food allergen.

    Product
    Organic traditions DARK CHOCOLATE GOLDEN BERRIES***DAIRY & SUGAR FREE 80% DARK CHOCOLATE; Pack sizes 3.5oz/100g, UPC 8 54260 00263 8; 5.3 oz (150g), UPC 8 54260 00266 9; 12kg bulk boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1652-2014·2014-06-04

    Siemens Linear Accelerator Recall for Unvalidated Stereotactic Accessories

    Siemens Medical Solutions is recalling nine Linear Accelerator units because they may be used with unvalidated stereotactic accessories.

    Product
    Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1664-2014·2014-06-04

    Beaver-Visitec Anterior Chamber Cannula Recalled for Sharp Tip Needle

    Beaver-Visitec International Inc. is recalling Visitec Anterior Chamber Cannulas because some units contain a sharp tip needle instead of a blunt tip cannula.

    Product
    Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1978-2014·2014-06-04

    Asian Bakery Recalls Velvet Cakes Due to Undeclared Wheat and Soy

    Asian Bakery is recalling round velvet cakes because they contain undeclared wheat and soy lecithin. The cakes were sold in Portland, Oregon, and Vancouver, Washington.

    Product
    Velvet cake; Round 8 cake packaged in plastic dome. Net Weight: 3lb 10oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1350-2014·2014-06-04

    Sandoz Recalls Cefpodoxime Proxetil Tablets Due to Stainless Steel Particles

    Sandoz, Inc. is recalling Cefpodoxime Proxetil tablets because they contain stainless steel particles. The recall covers 22,818 bottles distributed nationwide.

    Product
    CEFPODOXIME PROXETIL — CEFPODOXIME PROXETIL (CEFPODOXIME PROXETIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1661-2014·2014-06-04

    Medtronic Temporary Pacemaker Recalled for Pacing Rate Defect

    Medtronic is recalling 16,337 temporary pacemakers worldwide because oxidation on internal contacts can cause the pacing rate to increase unexpectedly to 180 pulses per minute.

    Product
    Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connecte
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1660-2014·2014-06-04

    Physio-Control Recalls LIFEPAK 1000 Defibrillators Due to Unexpected Shutdowns

    Physio-Control is recalling 96,611 LIFEPAK 1000 defibrillators because a software malfunction can cause the device to shut down unexpectedly, potentially failing to deliver a life-saving shock.

    Product
    LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2014·2014-06-04

    Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Performance Shift

    Abbott Laboratories is recalling 7,780 kits of ARCHITECT Intact PTH Calibrators because a performance shift may cause falsely elevated patient results.

    Product
    ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1972-2014·2014-06-04

    Price Chopper Tuscan White Bean Hummus Recalled for Undeclared Milk

    Golub Corporation is recalling Price Chopper brand Tuscan White Bean Hummus due to a labeling mix-up that resulted in an undeclared milk allergen.

    Product
    Price Chopper brand Hummus TUSCAN WHITE BEAN, NET WT. 10 OZ. Labels applied to clear plastic container with black rim on lid.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1975-2014·2014-06-04

    Asian Bakery Recalls Cakes Due to Undeclared Milk, Wheat, and Soy

    Asian Bakery is recalling Chernosliv cakes due to undeclared milk, wheat, and soy lecithin. The products were sold in Portland, Oregon, and Vancouver, Washington.

    Product
    Chernosliv cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 15.8 oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1653-2014·2014-06-04

    Siemens Recalls ADVIA Centaur TSH3 Ultra Ready Packs Due to Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur TSH3 Ultra Ready Packs because samples containing fluorescein may interfere with assay results.

    Product
    ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1667-2014·2014-06-04

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Software Display Errors

    Siemens is recalling 257 ACUSON SC2000 ultrasound systems due to software issues that may cause incorrect color flow data display and Doppler waveform failures.

    Product
    ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-1666-2014·2014-06-04

    B. Braun Recalls Sprotte Spinal Needles Missing Introducer Needles

    B. Braun Medical is recalling 24-gauge Sprotte Spinal Needles and Trays because the accompanying introducer needles are missing.

    Product
    Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1668-2014·2014-06-04

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Software Malfunction

    Siemens is recalling 177 ACUSON SC2000 ultrasound systems due to a software issue in the Stress Echo feature that may require studies to be repeated.

    Product
    ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1654-2014·2014-06-04

    Siemens ADVIA Centaur TSH3 Ultra Reagent Recall Due to Interference

    Siemens is recalling ADVIA Centaur TSH3 Ultra reagent kits because samples containing fluorescein may interfere with test results.

    Product
    ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1973-2014·2014-06-04

    Price Chopper Roasted Garlic Hummus Recalled for Labeling Errors

    Golub Corporation is recalling Price Chopper brand Roasted Garlic Hummus due to a mix-up in nutrition panel and ingredients labeling.

    Product
    Price Chopper brand Hummus ROASTED GARLIC, NET WT. 10 OZ. Labels applied to clear plastic container with black rim on lid.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1665-2014·2014-06-04

    GE Healthcare Recalls Centricity PACS Workstation Due to Image Rejection Error

    GE Healthcare is recalling 297 Centricity PACS Workstations because a software defect may cause images from previously displayed studies to be rejected unintentionally.

    Product
    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review work
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1355-2014·2014-06-04

    Wockhardt Recalls Metoprolol Succinate Extended-Release Tablets Due to Dissolution Failure

    Wockhardt USA LLC is recalling 8,712 bottles of Metoprolol Succinate Extended-Release Tablets, 100 mg, because they failed dissolution testing.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1657-2014·2014-06-04

    Siemens ADVIA Centaur VitD 500 Test Recalled for Fluorescein Interference

    Siemens is recalling ADVIA Centaur VitD 500 test kits because fluorescein samples may interfere with assay results.

    Product
    ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1659-2014·2014-06-04

    Siemens Recalls ADVIA Centaur BRAHMS PCT 100 Test Kits Due to Interference

    Siemens Healthcare Diagnostics is recalling 16,302 ADVIA Centaur BRAHMS PCT 100 test kits because samples containing fluorescein may interfere with assay results.

    Product
    ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1974-2014·2014-06-04

    Borden Vitamin D Milk Recalled for Excess Vitamin D Content

    Borden Dairy Co. is recalling Vitamin D Milk because it contains more than double the labeled amount of Vitamin D.

    Product
    Vitamin D Milk GRADE A PASTEURIZED HOMOGENIZED; 4-oz paper, 300-gal totes, Gallons, 1/2 gallons, pints, quarts, paper 1/2 pints, 5-gal dispense bags. INGREDIENTS: MILK AND VITAMIN D3. Product is sold under the following brand names and UPC codes: American Fare: Gal: 0 72000 1523
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1656-2014·2014-06-04

    Siemens ADVIA Centaur VitD 100 Test Recalled Due to Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems VitD 100 test kits because fluorescein samples may interfere with assay results.

    Product
    ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1662-2014·2014-06-04

    AGFA Recalls IMPAX CV Pediatric Echo Reporting Software Due to Defect

    AGFA Corp. is recalling IMPAX CV Pediatric Echo Reporting software in South Carolina due to a known software defect in the OCR service.

    Product
    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1655-2014·2014-06-04

    Siemens ADVIA Centaur TSH3 Ultra Recalled for Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra kits because fluorescein samples may interfere with test results.

    Product
    ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1352-2014·2014-06-04

    PediaCare Nighttime Cold Syrup Recalled for Diphenhydramine Precipitate

    Prestige Brands Holdings is recalling PediaCare Nighttime Multi-Symptom Cold syrup due to the presence of diphenhydramine precipitate in the solution.

    Product
    PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1663-2014·2014-06-04

    Siemens Recalls MAGNETOM Aera Systems Due to Missing Operator Manuals

    Siemens is recalling five MAGNETOM Aera magnetic resonance systems because a processing error may have prevented some users from receiving their Operator Manuals.

    Product
    MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or func
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Drugs)·D-1353-2014·2014-06-04

    PediaCare Day & Night Cold Syrup Recalled for Precipitate

    Prestige Brands Holdings is recalling PediaCare Day & Night Cold syrup bottles due to the presence of precipitate.

    Product
    PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V291000·2014-06-02

    Jaguar Recalls 2013-2014 XF Models Due to Brake Pipe Wear

    Jaguar is recalling 2013-2014 XF vehicles because the rear brake pipe may wear and leak fluid, increasing crash risk.

    Product
    JAGUAR — JAGUAR XF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E035000·2014-06-02

    Roush Propane Fuel System Conversion Kits Recalled for Leak Risk

    Roush CleanTech is recalling propane fuel system conversion kits for Ford vans due to a potential leak at the fuel line fitting that could cause a fire.

    Product
    FUEL SYSTEM, OTHER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V292000·2014-06-02

    Jaguar Recalls 2013 XJ Vehicles Due to Airbag Software Defect

    Jaguar is recalling 2013 XJ vehicles because generic software in the Restraints Control Module may prevent the airbag system from operating correctly, increasing injury risk in a crash.

    Product
    JAGUAR — JAGUAR XJ
    Category
    Vehicle
    Distribution
    Distributed nationwide

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