The Recall Desk

Archive

December 2012 recalls

411 recalls were announced in December 2012.

What the numbers show

Critical
23
Severe
79
High
198
Moderate
100
Low
11

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

Which agencies issued them

201–300 of 411

  • LowFDA (Drugs)·D-092-2013·2012-12-19

    Physicians Total Care Recalls Subpotent Enjuvia Tablets

    Physicians Total Care is recalling Enjuvia tablets due to low assay results. The recall is limited to a specific lot and expiration date.

    Product
    Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6165-1.
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·12V593000·2012-12-18

    Champion Bus Recalls Wheelchair Lifts Due to Fire Risk

    Champion Bus is recalling certain 2006-2013 buses because a wheelchair lift cable may cause a short circuit and fire.

    Product
    CHAMPION — CHAMPION, CHAMPION BUS CHALLENGER, DEFENDER, CRUSADER, AMERICAN CRUSADER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13073·2012-12-18

    LG Recalls Top-Loading Washing Machines Due to Risk of Injury

    LG is recalling about 457,000 top-loading washing machines because an unbalanced load can cause the drum to come loose, posing a risk of injury and property damage.

    Product
    Top-Loading Washing Machines
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13072·2012-12-18

    Catalina Outdoor Fireplaces Recalled for Burn and Laceration Hazards

    Christmas Tree Shops is recalling Catalina Outdoor Fireplaces because the glass components can break when a fire is lit, posing a burn and laceration hazard.

    Product
    Catalina Outdoor Fireplaces
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13074·2012-12-18

    Norco Recalls 2011 Havoc Bicycles Due to Frame Crack Risk

    Norco is recalling 2011 Havoc 24-inch and 26-inch bicycles because the frame can crack at the top and down tube joint, posing a risk of injury or death.

    Product
    2011 Havoc Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·13071·2012-12-17

    Dunecraft Recalls Water-Absorbing Toys Due to Serious Ingestion Hazard

    Dunecraft is recalling Water Balz, Growing Skulls, H2O Orbs, and Fabulous Flowers toys because they can expand inside the body if swallowed, causing intestinal blockages.

    Product
    Water Balz, Growing Skulls, H2O Orbs "Despicable Me" and Fabulous Flowers toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V591000·2012-12-17

    New Flyer Transit Buses Recalled for Drive Shaft Access Panel Defect

    New Flyer is recalling 2,048 model year 2004-2011 transit buses because the drive shaft access panel may be insufficiently strong or secured, posing an injury risk if the drive shaft fails.

    Product
    NEW FLYER — NEW FLYER DE40LFR, DE40LFA, D40LFR, D60LF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V588000·2012-12-17

    Autocar Recalls 2012-2013 Xpeditor Vehicles Due to Wheel Weld Defect

    Autocar is recalling 222 model year 2012-2013 Xpeditor vehicles because a weld defect may cause the wheel disc to separate from the rim, potentially leading to a crash.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V587000·2012-12-14

    Taylor-Dunn Recalls 2011 Trident LSVs for Steering Shaft Weld Defect

    Taylor-Dunn is recalling 2011 Trident low speed vehicles because the steering wheel shaft may be insufficiently welded, potentially causing loss of steering control.

    Product
    TAYLOR-DUNN — TAYLOR-DUNN TRIDENT LSV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V586000·2012-12-13

    Blue Bird Recalls 2013 Vision School Buses for Steering Defect

    Blue Bird is recalling 222 2013 Vision school buses because improperly torqued steering components may separate, causing loss of control.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13067·2012-12-13

    Enesco Recalls Shelly's Diner Collectible Due to Fire Hazard

    Enesco is recalling Shelly's Diner collectibles because the power adapter can overheat and melt, posing a fire hazard. No injuries or property damage have been reported.

    Product
    Shelly's Diner® Collectible Ceramic
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13069·2012-12-13

    Easy-Rest Classic Mattresses Recalled for Fire Hazard

    Easy-Rest is recalling about 3,800 Classic 5 Foam Core mattresses because they fail to meet federal flammability standards, posing a fire hazard.

    Product
    Classic by Easy-Rest Classic 5 Foam Core Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0745-2013·2012-12-12

    Kennys Farmhouse Cheese Recalls Vacuum-Packed Monterey Jack Cheese

    Kennys Farmhouse Cheese is recalling vacuum-packed Monterey Jack cheese due to potential Listeria monocytogenes contamination. The product was distributed in six states.

    Product
    Monterey Jack , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0743-2013·2012-12-12

    Kennys Farmhouse Cheese Recalls Vacuum-Packed Colby Cheese Due to Listeria

    Kennys Farmhouse Cheese is recalling vacuum-packed Colby cheese due to potential Listeria monocytogenes contamination. The product was distributed in six states.

    Product
    Colby , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0744-2013·2012-12-12

    Kennys Farmhouse Cheese Recalls Chipotle Colby Due to Listeria Risk

    Kennys Farmhouse Cheese is recalling vacuum-packed Chipotle Colby cheese in multiple sizes due to potential Listeria monocytogenes contamination.

    Product
    Chipotle Colby , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0803-2013·2012-12-12

    Boulder Ice Cream Recalls Peanut Butter Frozen Yogurt for Salmonella Risk

    Boulder Ice Cream is recalling Yoki Bliss Peanut Butter frozen yogurt due to potential Salmonella contamination from peanut ingredients.

    Product
    Yoki Bliss Peanut Butter frozen yogurt, 1 gallon, packaged in plastic containers, manufactured by Fresca Foods, CO.
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Food)·F-0805-2013·2012-12-12

    Legendary Baking Recalls Apple Lattice Pies Due to Undeclared Eggs

    Legendary Baking is recalling 726 Apple Lattice Pies because they may contain undeclared eggs, posing a risk to people with egg allergies.

    Product
    Apple Lattice Pie (9-inch, 36oz). Pies are sealed in a brown cardboard box with a see-through plastic label and sold as a fresh item at the consumer level.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0802-3013·2012-12-12

    Boulder Ice Cream Peanut Butter Cup Recalled for Salmonella Risk

    Boulder Ice Cream is recalling Peanut Butter Cup ice cream due to potential Salmonella contamination from peanut ingredients.

    Product
    All Natural Boulder Ice Cream Peanut Butter Cup, 2.5 gallon, packed in plastic packaging, manufactured by Fresca Foods, CO. All Natural Boulder Ice Cream Peanut Butter Cup, 1 pint, packed in semi flexible paper packaging, manufactured by Fresca Foods, CO.
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Food)·F-0795-2013·2012-12-12

    Breedlove Foods Recalls Vitanut Pro IC Due to Salmonella Risk

    Breedlove Foods, Inc. is recalling Vitanut Pro IC, 50 g, because it may be contaminated with Salmonella from peanut paste supplied by Sunland, Inc.

    Product
    Vitanut Pro IC, 50 g
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0801-2013·2012-12-12

    Boulder Ice Cream Recalls Elvis Ice Cream Due to Salmonella Risk

    Boulder Ice Cream is recalling Elvis Ice Cream manufactured by Fresca Foods due to potential Salmonella contamination from peanut ingredients.

    Product
    Elvis Ice Cream, 2.5 gallon, packed in a plastic container, manufactured by Fresca Foods, CO.
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Food)·F-0746-2013·2012-12-12

    Kennys Farmhouse Cheese Recalls Mild Cheddar for Listeria Contamination

    Kennys Farmhouse Cheese is recalling vacuum-packed Mild Cheddar cheese due to Listeria monocytogenes contamination. The product was distributed in six states.

    Product
    Mild Cheddar , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0797-2013·2012-12-12

    Tomales Bay Foods Recalls Pondhopper Cheese Due to Listeria Risk

    Tomales Bay Foods is recalling specific Pondhopper cheese wheels because testing found Listeria monocytogenes. Consumers should discard or return the product.

    Product
    Tumulo Farms, Pondhopper Cheese; any cut or partial wheels, wrapped in cheese paper with with type of cheese marked with magic marker and a Tomales Bay Foods sticker applied. Product is cut and packaged by Tomales Bay Foods, Petaluma, CA
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0467-2013·2012-12-12

    iwalk BiOM Battery and Charger Recalled for Overheating and Smoke Risk

    iwalk inc is recalling BiOM lower leg system batteries and chargers because they may overheat and smoke during charging.

    Product
    BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0804-2013·2012-12-12

    Sukhi's Red Curry Vegetables Recalled Due to Shrimp Packaging Error

    Jagpreet Enterprises is recalling Sukhi's Red Curry Vegetables because some boxes were mistakenly packaged with shrimp, posing a risk to consumers with shellfish allergies.

    Product
    Sukhi's Gourmet Indian Food; Red Curry Vegetables; 9 oz. package. Manufactured by Jagpreet Enterprises dba Sukhi's Gourmet Indian Foods; Hayward, CA 94545
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0741-2013·2012-12-12

    Omya Recalls Food Grade Ground Limestone Due to Salmonella Risk

    Omya Inc. is voluntarily recalling specific lots of food grade ground limestone processed in Arizona due to the possible presence of Salmonella.

    Product
    Ground limestone also known as calcium carbonate. Omya's food grade ground limestone products. All bulk with no product labeling. Product Container Size Omya-Cal FG-10 AZ 50 lb. bags 2500 lb. bulk bags
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0800-2013·2012-12-12

    Boulder Ice Cream Recalls Serano Gelato Chocolate Peanut Butter for Salmonella Risk

    Boulder Ice Cream is recalling Serano Gelato Chocolate Peanut Butter due to potential Salmonella contamination from peanut ingredients.

    Product
    Serano Gelato Chocolate Peanut Butter, 16 oz, contained in a semiflexible paper container, manufactured by Fresca Foods, CO.
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Food)·F-0798-2013·2012-12-12

    Tomales Bay Foods Recalls Shepherd's Way Big Woods Blue Cheese

    Tomales Bay Foods is recalling specific lots of Shepherd's Way Big Woods Blue cheese due to the presence of Listeria monocytogenes detected by the California Department of Agriculture.

    Product
    Shepherd's Way Big Woods Blue cut wrapped in cheese paper with with type of cheese marked with magic marker and a Tomales Bay Foods sticker applied. Product is cut and packaged by Tomales Bay Foods, Petaluma, CA
    Category
    Food
    Distribution
    8 states
  • SevereNHTSA·12V581000·2012-12-12

    Can-Am Spyder GS and RS Fuel Vapor Hose Recall

    Bombardier is recalling 2008-2010 Can-Am Spyder GS and RS vehicles because fuel vapors may exit the engine compartment, posing a fire risk.

    Product
    CAN-AM — CAN-AM SPYDER GS, SPYDER RS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-089-2013·2012-12-12

    Caraco Recalls Tramadol Tablets Due to Foreign Metoprolol Contamination

    Caraco is recalling Tramadol HCl 50 mg tablets because a customer reported finding Metoprolol Tartrate tablets in a bottle.

    Product
    traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0789-2013·2012-12-12

    Zingerman's Bakehouse Coffeecake Recalled for Allergen Mislabeling

    Zingerman's Bakehouse is recalling Nueske's Bacon Apple Coffeecake because labels failed to identify milk, wheat, and soy allergens.

    Product
    Zingerman's Bakehouse Nueske's Bacon Apple Coffeecake Net wt. 1.25 lb
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0799-2013·2012-12-12

    Boulder Ice Cream Recalls Organic Gelato Due to Salmonella Risk

    Boulder Ice Cream is recalling Organic Gelato Chocolate Peanut Butter due to potential Salmonella contamination from peanut ingredients.

    Product
    Organic Gelato Chocolate Peanut Butter, 5 liter, contained in plastic packaging, manufactured by Fresca Foods, CO.
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-0464-2013·2012-12-12

    Merit Medical Systems Recalls Custom Procedural Trays Due to Missing Tape

    Merit Medical Systems is recalling 83 custom procedural trays because clear protective tape was not applied during manufacturing.

    Product
    Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the prod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0460-2013·2012-12-12

    Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Plastic Flash

    Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.

    Product
    18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighNHTSA·12V582000·2012-12-12

    Can-Am Spyder Fuel Cap Recall Due to Fire Risk

    Bombardier is recalling 2008-2012 Can-Am Spyder vehicles because the fuel cap may not seal properly, creating a fire hazard.

    Product
    CAN-AM — CAN-AM SPYDER RT, SPYDER GS, SPYDER RS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0796-2013·2012-12-12

    Sara Lee Coffee Cake Recalled for Undeclared Pecan Allergen

    Hillshire Brands is recalling Sara Lee Butter Streusel Coffee Cake because the packages contain Pecan Coffee Cake, resulting in an undeclared pecan allergen.

    Product
    Sara Lee Butter Streusel Coffee Cake, Net Wt. 11.5 oz ; 8 cakes per 5.75 lb case; Distributed by Sara Lee Corp., Downers Grove, IL 60515 U.S.A.; UPC: 032100023429
    Category
    Food
    Distribution
    28 states
  • HighFDA (Food)·F-0758-2013·2012-12-12

    Zingerman's Bakehouse Cookies Recalled for Missing Allergen Labeling

    Zingerman's Bakehouse is recalling Junior Triple Trouble Chocolate Cookies because the labels failed to identify milk and wheat as ingredients.

    Product
    Zingerman's Bakehouse Junior Triple Trouble Chocolate Cookies Net wt. 6 ounces
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0786-2013·2012-12-12

    Zingerman's Bakehouse Granola Recalled for Missing Milk Allergen Labeling

    Zingerman's Bakehouse is recalling Mary's Wild Oats Cranberry Almond Granola because the labels failed to identify milk as an ingredient source.

    Product
    Zingerman's Bakehouse Mary's Wild Oats Cranberry Almond Granola 1 lb
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0472-2013·2012-12-12

    Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Defect

    Biomet is recalling 36 OSS Knee Reamer Sleeves because the thin shaft reamer may get stuck and fail to slide into the sleeve.

    Product
    OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0459-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.

    Product
    18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Food)·F-0793-2013·2012-12-12

    Zingerman's Bakehouse Brownies Recalled for Allergen Mislabeling

    Zingerman's Bakehouse is recalling brownies because labels failed to identify milk, wheat, and soy allergens.

    Product
    Zingerman's Bakehouse Brownies -Magic & Black Magic (variety pack) Net wt. 1.2 lb
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0468-2013·2012-12-12

    Invivo Expression MRI Patient Monitoring System Recalled for Detached Caster Risk

    Invivo Corporation is recalling the Expression MRI Patient Monitoring System because a caster may detach during transport, causing the cart to fall.

    Product
    Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for sync
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients during surgery.

    Product
    24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0462-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients during surgery.

    Product
    24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0453-2013·2012-12-12

    OmniGuide BP-ROBOTIC Fiber Recalled Due to Glue Joint Failure

    OmniGuide, Inc. is recalling 45 units of BP-ROBOTIC single-use fibers because a glue joint failure may cause the device to shift and fall into the patient.

    Product
    OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0457-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.

    Product
    24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0475-2013·2012-12-12

    Philips Digital Diagnost Software Recall for Image Marker Error

    Philips is recalling Digital Diagnost Software R2.0.2 because a mirrored image marker can be mistaken for a patient side indicator.

    Product
    Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2013·2012-12-12

    Natus Olympic Cool-Cap Recalled Due to Frozen Screen Malfunction

    Natus Medical is recalling 324 Olympic Cool-Cap systems because the control module screen may freeze, causing the device to stop cooling infants without visible alarm.

    Product
    The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.

    Product
    24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0474-2013·2012-12-12

    Biomet Recalls Bio-Modular Humeral Heads Due to Missing Ion Implantation

    Biomet, Inc. is recalling four Bio-Modular Humeral Heads because they are missing the ion implantation feature, which may cause increased wear and shorter implant life.

    Product
    Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0466-2013·2012-12-12

    Philips and Neusoft Recall CT Scanners Due to Detaching Patient Table

    Philips and Neusoft are recalling 45 CT scanners because the patient table top can detach from the carrier, posing a risk of injury.

    Product
    NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and det
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip could detach and harm patients during surgery.

    Product
    24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0473-2013·2012-12-12

    Roche Recalls 78 Cobas 8000 Analyzers Due to Reagent Pipetting Defect

    Roche Diagnostics is recalling 78 Cobas 8000 Modular Analyzers because a probe positioning mismatch can cause insufficient reagent pipetting, potentially affecting test results.

    Product
    Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0471-2013·2012-12-12

    Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Risk

    Biomet is recalling 46 OSS Knee Reamer Sleeves because the thin shaft reamer may get stuck and fail to slide into the sleeve.

    Product
    OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2013·2012-12-12

    Siemens IRON Flex Reagent Cartridges Recalled for Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling IRON Flex reagent cartridges because environmental iron contamination can cause falsely elevated test results.

    Product
    Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of disea
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0455-2013·2012-12-12

    Stryker Neptune 2 Rover Recall Due to Binding Casters

    Stryker is recalling 154 Neptune 2 Rover units because a castor design defect can cause binding, leading to operator strain and back pain.

    Product
    Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid wa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1985-2012·2012-12-12

    Tomales Bay Foods Recalls Artisan Cheese for Listeria Risk

    Tomales Bay Foods is recalling specific artisan cheese varieties due to a positive environmental test for Listeria monocytogenes.

    Product
    Tomales Bay Foods brand Artisan Cheese in PARTIAL WHEELS of Cheese, from cheese makers in US (VA, VT, Ca, WI, OR, WA and UT) and Ireland, Italy, Switzerland, France, Holland and Greece. Varieties include Appalachian, Coolea, Cabot clothbound Cheddar, Big Rock Blue, Goat Gouda,
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0752-2013·2012-12-12

    Zingerman's Bakehouse Chocolate Cookies Recalled for Allergen Mislabeling

    Zingerman's Bakehouse is recalling Funky Chunky Chocolate Cookie Jrs. because the labels failed to identify milk and wheat as ingredients.

    Product
    Zingerman's Bakehouse Funky Chunky Chocolate Cookie Jrs. Net wt. 6 ounces
    Category
    Food
    Distribution
    2 states

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