The Recall Desk

Archive

July 2012 recalls

445 recalls were announced in July 2012.

What the numbers show

Critical
14
Severe
94
High
219
Moderate
91
Low
27

Of the 445 recalls this month scored against our rubric, 3% are Critical, 21% are Severe.

Which agencies issued them

201–300 of 445

  • ModerateFDA (Devices)·Z-1997-2012·2012-07-18

    PSC Industries Recalls Surgical Forceps Due to Labeling Errors

    PSC Industries is recalling Bayonet Forceps due to typos in the inner packaging labels. The errors did not affect the part or lot numbers.

    Product
    Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1733-2012·2012-07-18

    Coca-Cola Zero Recalled for Off Odor and Taste

    Coca-Cola Refreshments is recalling 20 fl. oz. Coca-Cola Zero bottles in Missouri, Iowa, and Illinois due to off odor and taste caused by low levels of ammonium salts.

    Product
    Coca Cola Zero, 20 fl. oz., The Coca Cola Company.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1969-2012·2012-07-18

    Terumo Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions

    Terumo CVS is recalling 648 Advanced Perfusion System 1 units due to roller pump occlusion malfunctions that could prevent pump use during surgery.

    Product
    System 1 Base 220/240V 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 qualified medical professional who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1741-2012·2012-07-18

    Coca-Cola Cherry Zero Recalled for Mislabeling Sugar Content

    Coca-Cola Refreshments USA is recalling 119 cases of Coca Cola Cherry Zero in Texas because the label incorrectly states the product is sugar-free.

    Product
    Coca Cola Cherry Zero, 20 fl. oz. (1.25 pt), The Coca Cola Company.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1995-2012·2012-07-18

    PSC Industries Recalls Misbranded Electrosurgical Bayonet Forceps

    PSC Industries is recalling 5 units of Model #41604 Bayonet Forceps because the label incorrectly states the tip size is 0.5mm when it is actually 1.0mm.

    Product
    Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1964-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Gas Control Recall

    Terumo is recalling 992 Advanced Perfusion System 1 units due to reported difficulty adjusting the gas flow control knob.

    Product
    Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1979-2012·2012-07-18

    Smiths Medical Recalls HOTLINE 3 Blood and Fluid Warmer Units

    Smiths Medical is recalling 2,247 HOTLINE 3 Blood and Fluid Warmers because a microswitch may become damaged and unusable if not correctly installed.

    Product
    Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1999-2012·2012-07-18

    PSC Industries Recalls Irrigating Bayonet Forceps Due to Labeling Errors

    PSC Industries is recalling 125 units of Irrigating Bayonet Forceps because of typographical errors on the inner packaging labels.

    Product
    Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2012·2012-07-18

    Philips Medical Systems Recalls IntelliSpace Portal and Extended Brillance Workspace Software

    Philips Medical Systems is recalling 38 units of IntelliSpace Portal and Extended Brillance Workspace software due to inconsistent diagnostic results when using specific time-based methods.

    Product
    IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1743-2012·2012-07-18

    Winter Gardens Maryland Style Crab Soup Recalled for Processing Temperature Issue

    Winter Gardens Quality Foods is recalling Maryland Style Crab Soup due to a possible processing temperature issue during production.

    Product
    Maryland Style Crab Soup 2340 Net Weight 4-4LBS. Winter Garden Quality Foods, Inc. 304 Commerce St. New Oxford, PA 17350
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-1744-2012·2012-07-18

    Winter Garden Quality Foods Recalls Cream of Crab Soup for Processing Issue

    Winter Garden Quality Foods is recalling specific lots of Cream of Crab Soup due to a possible processing temperature issue during production.

    Product
    FF Cream of Crab Soup 3109 Net Weight 4-4 LB. Keep Refrigerated Winter Garden Quality Foods, Inc. 304 Commerce St. New Oxford, PA 17350
    Category
    Food
    Distribution
    4 states
  • LowFDA (Food)·F-1732-2012·2012-07-18

    FDA Recalls Middle-Age Energy Booster Tablets Due to Unapproved Ingredients

    H & L Jerch Sales, Inc. is recalling 1,981 bottles of Middle-Age Energy Booster tablets nationwide because they contain unapproved synthetic botanical ingredients.

    Product
    Middle-Age Energy Booster bottles of 60 tablets taken orally Nokomis Research Inc Bell Lifestyle Products #65
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1925-2012·2012-07-18

    Maquet FLOW-i Anesthesia System Recalled for Technical Alarm Issue

    Maquet is recalling 284 FLOW-i Anesthesia Systems because a technical alarm may be generated if the MAN/AUTO switch is not fully engaged.

    Product
    FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1991-2012·2012-07-18

    PSC Industries Recalls Button Switchpens Due to Labeling Errors

    PSC Industries is recalling Button Switchpens because the packaging labels incorrectly state the devices include a holster. The recall covers 725 units distributed nationwide.

    Product
    Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1730-2012·2012-07-18

    Erosyn tablets recalled for unapproved synthetic botanical ingredients

    H & L Jerch Sales is recalling Erosyn tablets because they contain synthetic equivalents of botanical constituents that have not been approved for use in dietary supplements.

    Product
    Erosyn bottles of 30 tablets taken orally Nokomis Research Inc Bell Lifestyle Products #7
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1729-2012·2012-07-18

    FDA Recalls Eroxil Tablets Containing Unapproved Synthetic Botanical Ingredients

    H & L Jerch Sales, Inc. is recalling Eroxil tablets nationwide because they contain synthetic equivalents of spermine and/or spermidine, which are not approved for use in dietary supplements.

    Product
    Product Name: Eroxil bottles of 30 tablets taken orally Nokomis Research Inc #6
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1411-2012·2012-07-18

    Qualitest Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities

    Vintage Pharmaceuticals is recalling 54,431 bottles of Hydrocortisone and Acetic Acid Otic Solution because impurity levels exceeded specifications.

    Product
    HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1998-2012·2012-07-18

    PSC Industries Recalls Surgical Forceps Due to Labeling Errors

    PSC Industries is recalling 40 units of Model #20-1360K surgical forceps because of typos in the inner packaging labels. The errors did not affect the part or lot numbers.

    Product
    Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords -
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1994-2012·2012-07-18

    PSC Industries Recalls Bipolar Bayonet Forceps Due to Packaging Labeling Error

    PSC Industries is recalling 7 units of Bipolar Bayonet Forceps because the manufacturer symbol was incorrectly replaced by the expiry symbol on the packaging.

    Product
    Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1996-2012·2012-07-18

    PSC Industries Recalls Bayonet Forceps Due to Incorrect Expiration Date

    PSC Industries is recalling 80 units of Bayonet Forceps because the outer carton lists an incorrect sterile expiration date, though the individual pouch labels are correct.

    Product
    Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Ol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1990-2012·2012-07-18

    PSC Industries Recalls Button Switch Pen Electrodes Due to Labeling Errors

    PSC Industries is recalling 50 units of Button Switch Pen Electrodes due to a labeling error where the manufacturer symbol replaced the expiration date symbol.

    Product
    Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V341000·2012-07-16

    Forest River Recalls 2005-2011 Motorhomes Due to Electrical Fire Risk

    Forest River is recalling 1,069 Berkshire and Charleston motorhomes because a transfer switch may fail under heat, increasing the risk of fire and electrical damage.

    Product
    CHARLESTON — CHARLESTON, BERKSHIRE 410DST, 405QS, 400TS, 400QS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V334000·2012-07-16

    Nova Bus Recalls 2012 LFS Transit Buses for Brake Valve Defect

    Nova Bus is recalling 2012 LFS transit buses because a brake valve plunger may fracture, potentially reducing braking ability and increasing crash risk.

    Product
    NOVA BUS — NOVA BUS NOVA LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V332000·2012-07-16

    Kenworth T680 Recalled for Weak Upper Bunk Restraint Belts

    PACCAR is recalling 2013 Kenworth T680 trucks because the upper bunk restraint belts may be weaker than specified, increasing injury risk in crashes.

    Product
    KENWORTH — KENWORTH T680
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V331000·2012-07-16

    Volkswagen Recalls 2012 Beetles for Non-Compliant Summer Tires

    Volkswagen is recalling 2012 Beetles because some were equipped with summer tires that do not meet federal safety standards, potentially increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN BEETLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V329000·2012-07-12

    Porsche Recalls 2011-2012 Cayenne and Panamera Turbo Models for Fire Risk

    Porsche is recalling 2011-2012 Cayenne and Panamera Turbo models because a defective turbocharger part may fracture, causing oil to enter the exhaust system and increasing the risk of a fire.

    Product
    PORSCHE — PORSCHE CAYENNE, PANAMERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V328000·2012-07-12

    Nissan Recalls 2012 Juke Vehicles Due to Rear Seat Striker Weld Defect

    Nissan is recalling 11,076 model year 2012 Juke vehicles because an incomplete weld may cause the rear seat back striker to separate in a crash, increasing injury risk.

    Product
    NISSAN — NISSAN JUKE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12221·2012-07-12

    Chicco Polly High Chairs Recalled Due to Laceration Hazard

    CPSC recalls Chicco Polly high chairs because children can fall against rear leg pegs, causing lacerations and other injuries.

    Product
    Chicco Polly High Chair
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·12224·2012-07-12

    Molenaar Recalls Folding Step Stools Due to Fall Hazard

    Molenaar LLC is recalling about 3,700 folding step stools because they can break or collapse unexpectedly, posing a fall hazard to consumers.

    Product
    Folding Step Stool
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1687-2012·2012-07-11

    Hannaford Mini Frosted Cookies Recalled for Undeclared Egg

    Hannaford Bros. is recalling 990 units of Mini Frosted Cookies sold in New England and New York due to undeclared egg.

    Product
    Hannaford brand Mini Frosted Cookies, 10 oz UPC # 4126872374
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1937-2012·2012-07-11

    DePuy Spine Side Fire Needles Recalled for Breakage Reports

    DePuy Mitek is recalling 683 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage during use.

    Product
    Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1939-2012·2012-07-11

    DePuy Spine Side Fire Needles Recalled for Breakage Reports

    DePuy Mitek is recalling 530 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage.

    Product
    Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1699-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Milk, Soy, and Wheat Allergens

    Mexicantown Wholesale recalled 26 units of Mexican Sweet Bread for undeclared milk, soy, and wheat allergens. The product was distributed in Canada.

    Product
    MUFFINS PLAIN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 21-MAY-12
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1915-2012·2012-07-11

    DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1719-2012·2012-07-11

    Seoul Trading Recalls Salted Fermented Oysters Due to Insanitary Conditions

    Seoul Trading Inc. is recalling two types of salted and fermented oysters distributed in Oregon and Washington because they were prepared under insanitary conditions.

    Product
    Na-Rae NR, Salted & Fermented Oyster, item no. MA1159, net wt. 44 lb per case. Cho-Rip-Dong Salted & Fermented Oyster, item no. MB3025, net wt. 7.4 oz per bag.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1923-2012·2012-07-11

    DePuy Recalls Luster Hip Stems Implanted with Metal-on-Metal Articulations

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1683-2012·2012-07-11

    Tree Top Recalls Pear Juice Concentrate Due to Arsenic Levels

    Tree Top Inc is recalling 6,708 gallons of pear juice concentrate because it contains inorganic arsenic levels exceeding FDA chronic exposure concerns.

    Product
    Pear juice concentrate 70 Brix in 55 gallon steel drums with plastic liner that are filled to 52 gallons. Labeled in part: "CLAREX PEAR JUICE CONCENTRATE "cRc-KOSHER"***52 GALLONS" and "TREE TOP***PEAR CONCENTRATE TYPE III***RESOURCE #: 4200815003***Selah, Wa. 98942***MADE IN US
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1940-2012·2012-07-11

    DePuy Spine Side Fire Needles Recalled for Breakage Reports

    DePuy Mitek is recalling 6,979 Confidence Spinal Cement System Side Fire Needles due to reports of breakage. The needles are used to place bone cement in the spine.

    Product
    Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1905-2012·2012-07-11

    Invacare Recalls TDX Power Wheelchairs Due to Fire and Injury Risk

    Invacare is recalling specific TDX power wheelchairs because a defect in the post fuse assembly could cause a short circuit, leading to fire and serious injury.

    Product
    TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1938-2012·2012-07-11

    DePuy Spine Side Fire Needles Recalled for Breakage Reports

    DePuy Mitek is recalling 704 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage.

    Product
    Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1901-2012·2012-07-11

    CareFusion Infant Y Connector Recall Due to Spontaneous Cracking

    CareFusion is recalling AirLife Infant Patient Y Connectors because the adapter may crack, causing a leak that reduces the air volume delivered to ventilated patients.

    Product
    AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1718-2012·2012-07-11

    Seoul Trading Recalls Frozen Rice Cake and Mussel Product

    Seoul Trading Inc. is recalling Nol-Boo Global Frozen Rice Cake & Mussel due to potential contamination from insanitary conditions.

    Product
    Nol-Boo Global Frozen Rice Cake & Mussel, Item no. EN5011, package in a plastic bag, net wt. 1.21 lb.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1717-2012·2012-07-11

    Seoul Trading Recalls Frozen Oysters Due to Insanitary Conditions

    Seoul Trading Inc. is recalling Cho-Rip-Dong Frozen Oysters because they were prepared or packed under insanitary conditions, potentially rendering them injurious to health.

    Product
    Cho-Rip-Dong Frozen Oysters in plastic bags: 1) Item no. BG1501, net wt. 1 lb.; 2) Item no. BG1521, net wt. 8 oz.; 3) Item no. BG1551, net wt. 3 lb.; 4) Item no. BG1601, net wt. 10 lb.; 5) Item no. BG1631, net wt. 1 lb.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1686-2012·2012-07-11

    Pendleton Flour Mills Recalls Wheat Germ Contaminated with Metal Fragments

    Pendleton Flour Mills is recalling bulk wheat germ contaminated with metal fragments. The product was distributed to consignees in California, Oregon, and Utah.

    Product
    Wheat Germ, brand name PFM, package in bulk tote, approximately 1650 lbs. per tote. Product SKU is 1344.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1721-2012·2012-07-11

    Deep Foods Recalls Crispy Coconut Cookies for Undeclared Milk

    Deep Foods Inc is recalling Crispy by TWI Foods Coconut Cookies because they may contain undeclared milk.

    Product
    Crispy by TWI Foods Coconut Cookies, Net Wt 7 oz., Product of Canada Manufactured by TWI Foods Inc. 2600 Drew Road, Mississauga, Ont, Canada L4T 3M5.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1698-2012·2012-07-11

    Mexican Sweet Bread Muffins Recalled for Undeclared Allergens

    Mexicantown Wholesale recalled 26 products of Mexican sweet bread muffins due to undeclared milk, soy, wheat, and FD&C yellow #6.

    Product
    MUFFINS CHOCOCHIPS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 24-MAY-12
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·12E026000·2012-07-11

    John Deere 8.1L Natural Gas Engine Turbocharger Recall

    Deere & Company is recalling certain 8.1-liter compressed natural gas engines due to potential turbocharger failures that may cause smoke, fire, and stalling.

    Product
    ENGINE AND ENGINE COOLING:ENGINE:OTHER FUEL TYPES:TURBO/SUPERCHARGER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1697-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Milk, Wheat, and Dye

    Mexicantown Wholesale is recalling Tortugas Mexican Sweet Bread for undeclared milk, wheat, and FD&C Yellow #6.

    Product
    TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1914-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is recalling ULTIMA LX and LUSTER cemented polished femoral hip stems implanted with metal-on-metal articulations due to a field safety notice.

    Product
    ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1707-2012·2012-07-11

    FDA Recalls Carrot Juice Due to Potential Botulism Contamination

    Healthy Choice/Island Blends is recalling 118 gallons of carrot juice sold in California due to potential Clostridium botulinum contamination.

    Product
    Carrot juice. Labeling reads in part:"***LIQUID GOLD 24K CARROT JUICE***JUICE CONNECTION LOS ANGELES CALIFORNIA 90058*** 7 62313 00130 0***INGREDIENTS: PASTEURIZED CARROT JUICE***".
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1900-2012·2012-07-11

    CareFusion AirLife Infant Breathing Circuits Recalled for Cracking Adapter

    CareFusion is recalling AirLife infant breathing circuits because a Y adapter may crack, causing a leak that reduces air delivery to ventilated patients.

    Product
    AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1685-2012·2012-07-11

    Newly Weds Foods Recalls Firewood Grill Seasoning Due to Salmonella

    Newly Weds Foods is recalling Firewood Grill Seasoning X2 because it was manufactured with a yeast extract contaminated with Salmonella.

    Product
    Firewood Grill Seasoning X2, 25 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G51189
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1690-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Soy Allergens

    Mexicantown Wholesale recalled 26 units of Mexican Sweet Bread due to undeclared soy ingredients.

    Product
    MUFFIN PLAIN (MEXICAN SWEET BREAD) IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz, UPC: 9564000029; and item #001
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1693-2012·2012-07-11

    Mexican Bread Recalled for Undeclared Yellow #6 Dye

    Mexicantown Wholesale is recalling Conchas (Mexican Bread) for undeclared Yellow #6. The recall affects products distributed in Canada.

    Product
    CONCHAS: 1) CONCHAS (MEXICAN BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz, UPC: 0895640000; and item #002; 2) CONCHAS (MEXICAN BREAD) IMPORTED BY FIESTA WHOLESALE 226-440-3033 MY LITTLE MEXICO 4/4.0oz;, UPC 0895640000; 3) CONCHAS (MEXICAN BREAD) IMPORTED BY FIESTA
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1908-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.

    Product
    ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system wa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·12219·2012-07-11

    Nikon Recalls Digital SLR Camera Battery Packs Due to Burn Hazard

    Nikon is recalling specific EN-EL 15 lithium-ion battery packs sold with D800 and D7000 cameras because they can overheat and melt, posing a burn risk.

    Product
    Nikon digital SLR camera battery packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12V330000·2012-07-11

    Turtle Top Recalls Buses with Stuck Roof Hatches

    Turtle Top is recalling 361 commercial buses because roof hatches may be too hard to open in an emergency, potentially hindering passenger exit.

    Product
    TURTLE TOP — TURTLE TOP VANTERRA, TERRA TRANSPORT, ODYSSEY XL, ODYSSEY LT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1684-2012·2012-07-11

    Newly Weds Foods Recalls Turkey Marinade Due to Salmonella Risk

    Newly Weds Foods is recalling 50 lb. bags of Turkey Dripping Type Marinade X1 because it was made with a yeast extract contaminated with Salmonella.

    Product
    Turkey Dripping Type Marinade X1, 50 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G00988
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1695-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Sulfites

    Mexicantown Wholesale is recalling Tacos de Manzana (Mexican Sweet Bread) due to undeclared sulfites. The product was distributed in Canada.

    Product
    TACOS DE MANZANA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 3.4oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1708-2012·2012-07-11

    Ultradent Recalls Cinnamon Xylishield Gum Due to Missing Soy Allergen Labeling

    Ultradent is recalling 36 lots of Cinnamon Xylishield gum because the packaging fails to list soy as an ingredient. The gum was distributed globally.

    Product
    Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8419.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1705-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Food Dyes

    Mexicantown Wholesale recalled 26 units of Empanadas de Pina for containing undeclared Yellow #6 and Yellow #5.

    Product
    EMPANADAS DE PINA (MEXICAN SWEET BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 MANUFACTURED BY MEXICANTOWN WHOLESALE DETROIT MI 48210 3.4oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1934-2012·2012-07-11

    Aesculap S4 Cervical Revision Instruments Recalled for Tolerance Issues

    Aesculap Implant Systems LLC is voluntarily removing S4 Cervical Revision Instruments because they may not thread into screws properly during surgery.

    Product
    S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1711-2012·2012-07-11

    Cedar's Bakery White Pita Bread Recalled for Wheat Allergen Mislabeling

    Cedar's Bakery is recalling White Pita Bread because the wheat flour ingredient is not labeled as an allergen.

    Product
    Cedar's Bakery Pita Bread, 10 loaves, White; ingredients flour water,yeast, sugar, salt. Nt. Wt. 22 oz.(1 lb. 6 oz. - 624 GMs)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1696-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Yellow 6

    Mexicantown Wholesale is recalling 26 units of Mexican Sweet Bread imported by El Campeon Leamington due to undeclared Yellow 6.

    Product
    MAGDALENAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1909-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.

    Product
    ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system wa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2012·2012-07-11

    Zimmer Recalls PathFinder NXT Pivoting Percutaneous Rod Holder

    Zimmer, Inc. is recalling 77 units of the PathFinder NXT Pivoting Percutaneous Rod Holder because the set screw may break, preventing the surgeon from removing the rod during surgery.

    Product
    PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2012·2012-07-11

    DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal Articulations

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 2 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2012·2012-07-11

    DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns

    DePuy Orthopaedics is recalling Luster and Ultima LX hip stems implanted with metal-on-metal articulations due to a field safety notice.

    Product
    LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is recalling ULTIMA LX and LUSTER hip stems implanted with metal-on-metal articulations due to potential safety concerns.

    Product
    ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system wa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1692-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Artificial Dyes

    Mexicantown Wholesale recalled 26 units of Polvorones Fresa y Pina for containing undeclared artificial dyes. The products were distributed in Canada.

    Product
    POLVORONES FRESA Y PINA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1920-2012·2012-07-11

    DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Use

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1723-2012·2012-07-11

    Deep Foods Recalls Pistachio Cookies for Undeclared Milk and Almonds

    Deep Foods Inc. is recalling Crispy by TWI Foods Pistachio Cookies because they may contain undeclared milk and almonds.

    Product
    Crispy by TWI Foods Pistachio Cookies, Biscuit, Net Wt 7 oz. Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1899-2012·2012-07-11

    CareFusion AirLife Infant Respiratory Circuits Recalled for Cracking Adapter

    CareFusion is recalling AirLife Isothermal Breathing Circuits because the Y adapter may crack, causing a leak that reduces the air volume delivered to ventilated patients.

    Product
    AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1691-2012·2012-07-11

    Mexicantown Wholesale Recalls Muffins with Pecans for Undeclared Soy Allergen

    Mexicantown Wholesale is recalling specific muffin products containing pecans due to undeclared soy ingredients. The recall affects products distributed in Canada.

    Product
    Muffins with Pecans: 1) MUFFIN W/PECANS (MEXICAN BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4oz; UPC 9564000029, item #002; 2) MUFFIN W/PECANS MEXICAN SWEET BREAD IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz, UPC 9564000029;
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1700-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Yellow 6 Dye

    Mexicantown Wholesale is recalling Tortugas Mexican Sweet Bread due to undeclared Yellow 6 dye. The recall affects 26 products distributed in Canada.

    Product
    TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1704-2012·2012-07-11

    Mexican Bread Recalled for Undeclared Food Dyes

    Mexicantown Wholesale recalled Conchas (Mexican Bread) in Canada due to undeclared Yellow #5 and Yellow #6.

    Product
    CONCHAS (MEXICAN BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 4/4.0oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1720-2012·2012-07-11

    Deep Foods Recalls Crispy Almond Cake Rusk for Undeclared Milk

    Deep Foods Inc is recalling Crispy by TWI Foods Almond Cake Rusk because the product may contain undeclared milk.

    Product
    Crispy by TWI Foods Almond Cake Rusk, Biscuit, Net Wt 26.4 oz. Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court , Mississauga, Ont, Canada . L5S 1S3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1709-2012·2012-07-11

    Ultradent Recalls Cinnamon Xylishield Gum Due to Missing Soy Allergen Labeling

    Ultradent is recalling 36 lots of cinnamon Xylishield gum because the ingredients label failed to list soy, a major allergen.

    Product
    Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with black and white print writing. The product is advertised as a defense against cavities. Part number 8405.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1722-2012·2012-07-11

    Crispy Almond Cookies Recalled for Undeclared Milk Allergen

    Deep Foods Inc is recalling Crispy by TWI Foods Almond Cookies because they may contain undeclared milk. Consumers with milk allergies should not eat the product.

    Product
    Crispy by TWI Foods Almond Cookies, Biscuit, Net Wt 7 oz., Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1919-2012·2012-07-11

    DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal Components

    DePuy Orthopaedics issued a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·12220·2012-07-11

    Troxel Recalls Flexible Flyer Swing Sets Due to Fall Hazard

    The Troxel Company is recalling about 105,400 Flexible Flyer swing sets because see saw seats can break away, posing a fall hazard.

    Product
    Flexible Flyer Swing Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1912-2012·2012-07-11

    DePuy Recalls Cemented Polished Femoral Hip Stems Due to Metal-on-Metal Use

    DePuy Orthopaedics is issuing a Field Safety Notice for LUSTER and ULTIMA LX Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.

    Product
    ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1694-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Yellow #6

    Mexicantown Wholesale recalled 26 units of Cuernos Mexican sweet bread for containing undeclared Yellow #6. The products were distributed in Canada.

    Product
    CUERNOS: 1) CUERNOS/CROISSANT (MEXICAN SWEET BREAD/Pain sucre) IMPORTED BY MAX PRODUCTS LEAMINGTON 519-325-1176, 4 oz., UPC 9564000035; 2) CUERNOS PLAIN (MEXICAN SWEET BREAD/PAIN SUCRE) IMPORTED BY FIESTA WHOLESALE MISSISSAUGA ON. 416-833-5959 416-509-8349 4.0OZ, UPC: 9564000035
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1935-2012·2012-07-11

    Greiner Bio-One Recalls Vacuette Quickshield Complete Plus Blood Collection Devices

    Greiner Bio-One is recalling specific lots of Vacuette Quickshield Complete Plus devices due to a defect that may cause the safety shield to become loose and unstable.

    Product
    Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1907-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.

    Product
    ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system wa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2012·2012-07-11

    DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is recalling ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations due to a Field Safety Notice.

    Product
    ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1924-2012·2012-07-11

    DePuy Luster and Ultima Hip Stems Recalled for Metal-on-Metal Use

    DePuy Orthopaedics is recalling Luster and Ultima hip stems implanted with metal-on-metal articulations due to a field safety notice.

    Product
    LUSTER HIP SZ 10 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1921-2012·2012-07-11

    DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2012·2012-07-11

    DePuy Recalls Luster Hip Stems Implanted with Metal-on-Metal Articulations

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2012·2012-07-11

    DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems

    DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.

    Product
    ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system wa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1913-2012·2012-07-11

    DePuy Recalls Cemented Polished Femoral Hip Stems Implanted with Metal-on-Metal Articulations

    DePuy Orthopaedics is issuing a Field Safety Notice for LUSTER and ULTIMA LX Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.

    Product
    ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1936-2012·2012-07-11

    Microbiologics Recalls KWIK-QC Gram Stain Slides Due to Fixation Defect

    Microbiologics is recalling KWIK-QC Gram Stain Slides because the control organism is not properly fixated, which may lead to slide contamination and potential patient misdiagnosis.

    Product
    Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. They are microscope slide preparations contains specific organisms populatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1706-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Wheat, Milk, and Soy Allergens

    Mexicantown Wholesale is recalling 26 units of Mexican Sweet Bread for undeclared wheat, milk, and soy allergens. The products were distributed in Canada.

    Product
    MUFFINS PECAN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY 21-MAY-12 4.0oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1702-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Artificial Food Dyes

    Mexicantown Wholesale recalled Polvorones Con Fresa (Mexican Sweet Bread) for containing undeclared Yellow #6 and Red #40.

    Product
    POLVORONES CON FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1710-2012·2012-07-11

    Ultradent Recalls Xylishield Gum for Missing Soy Allergen Labeling

    Ultradent is recalling specific lots of Xylishield gum because the packaging failed to list soy as an ingredient. A separate lot of spearmint gum was also recalled due to accidental cinnamon flavoring.

    Product
    Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is aqua, blue and white with black, aqua and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8418.
    Category
    Food
    Distribution
    1 state

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