On December 11, 2008, the Food and Drug Administration (FDA) said it is going to add the most serious safety warning available to bowel-clearing drugs used before colonoscopies. The warning comes after the agency received more than 20 reports of a serious form of kidney failure in patients taking the drugs.

The now boxed warning will apply to Salix Pharmaceuticals’ Visicol and OsmoPrep, prescription tablets that have been found to also cause lethargy, drowsiness and swelling.

Labels on the drugs, which are also known as oral phosphate products, warn patients older than 55 to use them with caution, especially those patients who suffer from dehydration and kidney disease. Patients who take other medications that affect the kidneys should also be cautious when taking Visicol or OsmoPrep.

Kidney damage in patients may occur within days or weeks of taking the medications, but other symptoms may not appear until much later.

In addition to the medications’ warnings, Salix Pharmaceuticals will distribute a medication guide warning about the drugs’ risks. Salix Pharmaceuticals must also conduct a follow-up study to determine which patients are most vulnerable to kidney damage.

The potential for kidney damage was first linked to Visicol and OsmoPrep in 2006, and a recent petition submitted to the FDA asked the agency to place a boxed warning on the drugs.

Source: “Bowel-clearing drugs to get sternest FDA label,” MSNBC.com, December 11, 2008.

In November 2008, the United States Consumer Product Safety Commission announced it is investigating the design of recreational off-highway vehicles, such as Yamaha Motor Company’s Rhino, after reports of more than 30 fatal accidents.

The inquiry focuses on gaps in oversight of the products, which are larger than all-terrain vehicles (ATVs), seat two and have a protective roll cage. Current rules for conventional ATVs don’t apply to the recreational vehicles due to their designs, leaving the products unregulated. A seeming increase in deaths related to the vehicles led to the probe.

The Yamaha Rhino is at the center of the probe, with at least an estimated 30 consumer deaths. Other models include Polaris’ Razor, Honda Motor Company’s Big Red, Kawasaki Heavy Industries’s Mule, and Arctic Cat Inc.’s Prowler.

A California-based association for recreational off-highway vehicles is in the process of developing safety standards for review by early 2009. The commission intends to study how the vehicles are being used, how injuries are happening and how consumer behavior may cause injuries.

Source: Alan Ohnsman and Mary Jane Credeur, “US Agency reviews unregulated off-road vehicles after deaths,” Bloomberg.com, November 4, 2008.

On October 28, 2008, a jury ruled two Johnson & Johnson subsidiaries, Janssen Pharmaceutical Products and Alza, are responsible for the death of a 34-year-old woman who died from a painkiller overdose caused by a patch the companies manufactured. Johnson & Johnson was ordered to pay more than $13 million to the woman’s family.

The victim was an Army military policewoman who used Duragesic patches in combination with other painkillers after undergoing back surgery. Personal injury lawyers and family members of the deceased woman argued officials for Johnson & Johnson were aware of manufacturing defects in the company’s Duragesic patches, but sold the flawed devices anyway.

The product liability lawsuit was the third case over Duragesic patches to go to trial since 2006. Jurors have ruled against Johnson & Johnson in all three cases.

Duragesic patches were approved in 2000, but reports of adverse events related to the patches began occurring as early as 2001. The active ingredient in Duragesic patches is fentanyl, a drug under investigation by the U.S. Food and Drug Administration (FDA) due to reports of adverse respiratory events experienced by patients wearing the patch.

In July 2005, after a recall of Duragesic patches due to leaks, the United States Food and Drug Administration (FDA) began a probe of 120 fentanyl overdose deaths linked to Duragesic patches made by Johnson & Johnson and Mylan Laboratories Inc.

In an August 2008 U.S. Securities and Exchange Commission filing, Johnson & Johnson officials said Janssen, the distributor of the Duragesic patches, and Alza, the manufacturer, still face 60 product liability lawsuits over the patches.

Source: Jef Feeley, “J&J units must pay $13 million over pain-patch death, jury says,” Bloomberg.com, October 29, 2008.

In October 2008, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes announced that members of a medical panel unanimously advised against using GlaxoSmithKline’s controversial diabetes drug, Avandia. The Food and Drug Administration (FDA) also received a petition from consumer advocacy group Public Citizen asking the agency to ban the drug.

Avandia’s label already has a “black box” warning identifying 14 cases of liver failure caused by the drug, 12 of which resulted in liver-related deaths. Controversy surrounding the diabetes drug began in May 2007 when cardiologist Steve Nissen of the Cleveland Clinic published an article that found Avandia patients had a 43 percent higher chance of suffering a heart attack.

GlaxoSmithKline said it does not believe there is a connection between liver toxicity and Avandia. The FDA is reviewing Public Citizen’s petition. Officials from the agency have said there is a split within the agency over pulling Avandia off the market.

Avandia is a drug designed to help lower blood sugar in patients with Type 2 diabetes. It was approved by the FDA in 1999.

Source: Jennifer Corbett Dooren, “Leading medical groups advise against Avandia,” Wall Street Journal, October 31, 2008.

On October 29, 2008, Bridgestone Firestone North America Tire, LLC (BFNT) announced a recall of more than 160,000 imported tires because they were produced with insufficient tread base gauge. Consumers who continue to use recalled tires may notice tread separation or tread distortion, which could lead to a catastrophic injury from a car accident.

Included in the recall are 135,000 Firestone brand FR380 P235/75 R15 tires, imported into both the United States and Canada, and 27,000 LeMans Champion SE P235/75 R15 tires, imported into the United States.

The company said it has not received any reports of injuries related to the recalled Firestone tires. Consumers seeking information about identifying and inspecting tires may visit the company’s website.

Bridgestone Firestone North America Tire will notify owners of the recalled Firestone tires and will provide replacement tires. Owners may contact Bridgestone Firestone North America Tire at 1-800-465-1904, or may visit the company’s website.

For more information, consumers may also contact the National Highway Traffic Safety Administration’s Vehicle Safety Hotline at 1-888-327-4236, or visit SaferCar.gov.

Source: National Highway Traffic Safety Administration Campaign ID Number 08T026000, October 29, 2008.

On July 22, 2008, Zimmer Holdings, Inc. announced it will suspend marketing and sales of its Durom® Acetabular Component (Durom Cup) in the United States. The suspension is due to complaints from doctors that the artificial hip component is failing at a high rate.

The Durom cup is used in total hip replacement procedures, which are performed in more than 442,000 patients in the United States each year. The cup was developed to relieve pain and improve joint function in patients with severe hip degeneration due to arthritis or trauma.

In the months leading up to the suspension, some doctors complained the device was failing in their patients, who then underwent replacement surgery. Zimmer received complaints about loosenings of the Durom cup, prompting the company to launch an investigation to determine whether the product was defective.

The investigation found that experienced surgeons reported difficulty implanting the Durom cup. Zimmer asserts the product is not defective. Zimmer also cited evidence that the product was doing well in Europe, but the version of the Durom cup used in Europe differs from the version used in the United States. Surgeons in other countries also perform a different, relatively new kind of hip surgery.

Zimmer said sales and implantations of the Durom cup are to be halted until it can update the products label to provide more detailed surgical technique instructions and implement a surgical training program.

The Durom cup was first sold in the United States in 2006, and has been implanted in more than 12,000 patients. Zimmer expects the number of early replacement surgeries needed to be minimal, but hundreds of patients may need replacement surgeries in the next several years.

Sources: Barry Meier, “Complaints undermine hip device,” The New York Times, July 24, 2008; “Background on Durom® Cup Status,” Zimmer Holdings, Inc. announcement, July 22, 2008.

On September 5, 2008, a federal judge announced he was unsealing papers relating to Eli Lilly’s antipsychotic drug Zyprexa. The decision was part of a ruling giving class-action status to a lawsuit filed by insurance companies, pension funds and unions that want Eli Lilly to repay them billions of dollars for allegedly hiding the side effects of Zyprexa and marketing it for off-label use.

The papers were placed under a protective court order after they were produced by Eli Lilly in response to a 2004 lawsuit filed by patients who allege the drug caused excessive weight gain and diabetes. Two years later, a reporter for the New York Times reported on some of the papers, writing that Eli Lilly executives withheld information from doctors about Zyprexa’s association with obesity and high blood sugar. Since the report, researchers and insurance companies have filed for copies of the documents.

The federal judge’s release of the papers applies to only a small number of the papers, leaving many left sealed.

Also in September 2008, Idaho joined many other states in filing a lawsuit against Eli Lilly over Zpyrexa, alleging improper marketing that resulted in sick Idaho patients and the spending of a significant amount of money from Medicaid for low-income and disabled people.

Alaska has been the only state thus far to settle its Zyprexa lawsuit with Eli Lilly. The state was awarded $15 million.

Zyprexa is a drug approved by the United States Food and Drug Administration (FDA) to treat adults with schizophrenia and bipolar disorder. Eli Lilly is also seeking approval to treat the same disorders in teenagers.

Sources: Colleen LaMay, “Idaho presses case against best-selling medication,” Idaho Statesman, September 3, 2008; Mary Williams Walsh, “Judge to unseal documents on the Eli Lilly drug Zyprexa,” New York Times, September 6, 2008.

In 2000, a professional guitarist received an injection of the anti-nausea drug phenergan to treat a migraine. The injection of the drug, however, was not properly administered, causing her to lose her arm to gangrene. The woman won $6.8 million in a product liability lawsuit against Wyeth, the maker of the drug, on the basis that the company failed to sufficiently warn the public and doctors about the drug’s risks if not properly injected.

Wyeth has since appealed the lawsuit, arguing that because the United States Food and Drug Administration (FDA) approved the drug based on the information Wyeth presented, the company is not liable – a legal doctrine known as pre-emption. The case is now headed to the Supreme Court, which will test the doctrine for prescription drugs.

If the Court rules in favor of Wyeth, drugmakers will be shielded from product liability lawsuits involving FDA-approved prescription drugs, even if the drugmakers fail to disclose all risks associated with treatment. This would make the FDA the only regulator guaranteeing drug safety – a guarantee that may not be questioned by state-level lawsuits.

On August 14, 2008, the editors of the New England Journal of Medicine wrote an editorial claiming the FDA lacks the ability to adequately protect consumers against drugmakers’ treatments, citing 23 FDA-approved drugs that have been withdrawn from the market since 1997 due to safety risks. In addition, two former FDA commissioners and 47 state attorneys general oppose pre-emption, claiming the agency is unable to assume the role.

Pending the outcome of the Wyeth case, which is scheduled for November 3, several product liability lawsuits have been put on hold, including three involving GlaxoSmithKline PLC’s antidepressant Paxil. If the Court sides with Wyeth, these lawsuits, and dozens of others, could be dismissed.

Sources: Alicia Mundy, “Plaintiffs’ lawyers fight restrictions on product-liability suits,” Wall Street Journal, August 13, 2008; “Lawsuits help ensure drug safety, NEJM editors say,” Medical News Today, August 19, 2008.

On August 18, 2008, the Food and Drug Administration (FDA) reported it received reports of six cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta, a drug used to treat adults with type 2 diabetes. Two of the cases resulted in death, and the four others required hospitalization.

The FDA also reported it is working with the maker of Byetta, Amylin Pharmaceuticals, Inc., to add stronger and more prominent warnings about the risk of acute pancreatitis on the drug’s label.

The report came 10 months after an alert from the FDA warning healthcare professionals and consumers about the risk of pancreatitis in Byetta patients.

Byetta is a medicine given by injection to adults diagnosed with type 2 diabetes. Some patients have reported having severe, abdominal pain, raising the suspicion of acute pancreatitis. Byetta has prompted 30 postmarketing reports of acute pancreatitis, with 22 of the reports indicating patient improvement after discontinuing the drug.

Source: “Information for healthcare professionals: Exenatide (marketed as Byetta),” Food and Drug Administration Information Sheet, August 18, 2008.

On August 26, 2008, company officials for Amylin Pharmaceuticals, Inc. reported four additional deaths in Byetta patients, bringing the total number of patient deaths after developing pancreatitis to six. Earlier in the month, the Food and Drug Administration (FDA) reported two Byetta patient deaths and four hospitalizations; the four additional deaths are not connected to the four hospitalizations.

Co-marketed by Amylin and Eli Lilly, Byetta is an injected medication used to treat type 2 diabetes in adults. It was approved in 2005, and is used to improve blood sugar control. It can be combined with other diabetes drugs, but the recent reports of patient deaths have some questioning whether it should be used as a monotherapy.

The first two deaths reported by the FDA were attributed to hemorrhagic pancreatitis or necrotizing pancreatitis. Of the four additional deaths, one died from complications of gallbladder removal, one died from a relapse of leukemia, and a third died from intestinal bleeding after gallbladder removal; the cause of death for the fourth patient is not yet known.

Eli Lilly’s vice president of global patient safety said the prescribing information for Byetta has included information about pancreatitis since 2006, and this prescribing information was amended in 2007 to list pancreatitis as a precaution. Also in 2007, doctors were alerted about the potential for pancreatitis in Byetta patients.

While Byetta has not been identified as a cause for pancreatitis, analysts suspect an association between the drug and the disease. Type 2 diabetes patients have almost three times the risk of developing pancreatitis than the general population. But as of now, doctors believe the benefits of Byetta outweigh the risks.

Officials from Amylin and Eli Lilly are working with the FDA to decide on possible changes to Byetta’s warning label. Some executives have said the advisory could be upgraded to a higher warning, which may include the FDA’s strictest warning, the black box.

The surge of bad news for Byetta could have an effect on the approval of Byetta LAR, a once-weekly formulation currently in development. Eli Lilly, Amylin and Alkermes Inc. are expected to file for approval of the formulation in 2009.

Sources: Elizabeth Trotta, “Byetta talk leads Amylin to fall further,” TheStreet.com, August 27, 2008; Thomas Gryta, “UPDATE: Byetta concerns stoke worries for once-weekly version,” CNNMoney, August 27, 2008; Kathleen Doheny, “6 deaths reported from diabetes drug Byetta,” WebMD.com, August 27, 2008.

On August 25, 2008, the Food and Drug Administration (FDA) said it is working with Tysabri manufacturers to update the multiple sclerosis drug’s label after receiving two reports of patients diagnosed with a serious brain infection.

The agency received information about two cases of progressive multifocal leukoencephalopathy (PML) in European Tysabri patients, both of whom had been taking Tysabri for more than one year. Several years ago, Tysabri was withdrawn from the US market after three patients developed the same infection, which is usually fatal.

Authorities allowed the reintroduction of Tysabri under a safety program that prohibits patients from taking it together with other drugs that may also weaken the immune system. The two new patients who contracted the infection, however, were taking only Tysabri.

Biogen Idec and Elan Corp are working with the FDA to update Tysabri’s label to include information about the new cases of PML.

Sources: Jacob Goldstein, “FDA takes news of Tysabri-related infections in stride,” Wall Street Journal, August 26, 2008; “Information for Healthcare Professionals Natalizumab Injection for Intraveneous Use (marketed as Tysabri),” Food and Drug Administration InfoSheet, August 25, 2008.

On July 8, 2008, the Food and Drug Administration (FDA) announced it notified manufacturers of fluoroquinolone drugs that a warning on the product labeling concerning an increased risk of tendinitis and tendon rupture is necessary. Manufacturers must also provide a Medication Guide to patients detailing the potential side effects.

The agency made the announcement after completing a new analysis of literature and post-marketing adverse event reports. The analysis confirmed an association between the use of fluoroquinolones and tendon rupture, and also found a continuation of large numbers of tendon-related reports.

Further, the FDA informed the manufacturers of the drugs that a Risk Evaluation and Mitigation Strategy (REMS) will need to be performed to determine if the benefits of the drugs outweigh the risks. Companies are required to submit safety labeling changes to the FDA within 30 days, or to explain why they do not believe the change is necessary.

Fluoroquinolones are approved to treat or prevent specific bacterial infections. Medications considered as fluoroquinolones are:

• Cipro, made by Bayer,
• Cipro XR, made by Bayer,
• Proquin XR, made by Depomed, Inc.,
• Factive, made by Oscient Pharmaceuticals,
• Levaquin, made by Ortho-McNeil Pharmaceuticals,
• Avelox, made by Bayer,
• Noroxin, made by Merck & Co., Inc.,
• Floxin, made by Oscient Pharmaceuticals, and
• Ofloxacin, a generic drug.

Source: “FDA requests boxed warningson fluoroquinolone antimicrobial drugs,” Food and Drug Administration Press Release, July 8, 2008.

On July 17, 2008, Volvo Cars of North America LLC notified the National Highway Traffic Safety Administration (NHTSA) that it was recalling more than 1,000 2008 and 2008 Volvo C30, Volvo C70, Volvo S40 and Volvo V50 vehicles. The recall was initiated because a section of the power steering return line hose does not meet specifications, which could cause a sudden rupture of the hose.

If this were to occur, there would be a rapid drainage of the power steering fluid and a complete loss of power assistance, increasing the risk of a catastrophic injury from a car accident.

Volvo dealers will inspect and replace the steering return line hose assembly. Owners may contact Volvo at 1-800-458-1552. For more information, customers may also contact the National Highway Traffic Safety Administration’s Vehicle Safety Hotline at 1-888-327-4236, or visit safercar.gov.

Source: National Highway Traffic Safety Administration Campaign ID Number 08V329000, July 17, 2008.

On July 22, 2008, Sleep Innovations Inc. recalled about 120,000 Cuddly Comfort Pillows because a mechanical breakdown in the manufacturing process may cause the pillows to contain small metal fragments in the fiber-fill, which could pose a laceration hazard to consumers.

Recalled Cuddly Comfort Pillows were sold in packs of two, and each pillow is 20 inches wide by 26 inches long. They were sold in white, violet, blue, pink and yellow colors with the words “Sleep Innovations” printed on the tag. Only pillows with Registration Number PA-27156(CA) are included in the recall. Registration Numbers are found on the pillow’s tag.

Costco stores nationwide sold the recalled Sleep Innovations pillows from February 2008 through June 2008 for about $20. Consumers are advised to immediately stop using the recalled pillows and return them to any Costco store for a refund.

For more information, customers may contact Sleep Innovations at 866-656-0610, or visit the company’s website.

Source: “Sleep Innovations recalls pillows sold exclusively at Costco; metal fragments pose abrasion hazard,” US Consumer Product Safety Commission Alert #08-596, July 22, 2008.

On July 24, 2008, Cost Plus Inc. recalled about 8,600 Santorini Chairs because the weld can fail, causing the chair to collapse and posing a fall hazard to consumers. The company received four incident reports involving weld failure, though no injuries have been reported.

Included in the recall are black metal Santorini outdoor stacking chairs that have vertical bars on the back and horizontal bars across the base. Cost Plus and World Market stores nationwide sold the recalled chairs from January 2008 through April 2008 for about $50.

Consumers are advised to immediately stop using the chairs with side weld joints and return them to any Cost Plus or World Market store for a full refund or exchange. For more information, customers may contact Cost Plus at 877-967-5362, or at the company’s website.

Source: “Cost Plus recalls Santorini chairs due to fall hazard,” US Consumer Product Safety Commission Release #08-342, July 24, 2008.

On July 24, 2008, Fitness Associates Incorporated (F.A.I.), under license from Reebok International Ltd., recalled about 20,000 Reebok Studio Exercise Cycles because they pose a laceration hazard to consumers. The company received five reports of alloy cranks breaking during use, including three consumers who required stitches.

Reebok Studio Exercise Cycles are upright exercise bikes that are black with silver cranks, and that are used primarily in fitness centers and other institutional settings. There is a logo on the side of the recalled exercise cycle that shows a person riding a bicycle.

F.A.I. sold the recalled Reebok Studio Exercise Cycles to health clubs and specialty fitness dealers nationwide from 1997 through 2000. F.A.I. is no longer in business.

Consumers are advised to immediately stop using the recalled exercise cycles and contact Reebok International Ltd. at 800-382-3823 to receive a discount on an exercise cycle model. For more information, customers may also visit the company’s website.

Source: “Reebok International Ltd. recalls exercise cycles due to laceration hazard,” US Consumer Product Safety Commission Release #08-340, July 24, 2008.

On July 21, 2008, Agricola Zaragoza, Inc. recalled all jalapeno peppers distributed since June 30 because they may be contaminated with Salmonella, which could cause foodborne illness from Salmonella. The recalled jalapeno peppers, distributed to customers in Georgia and Texas, were shipped in 35-pound plastic crates and in 50-pound bags with no brand name or label.

Sampling by the Food and Drug Administration (FDA) led to the recall. The agency found that the recalled Agricola Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for a current Salmonella outbreak that may have caused 1,200 illnesses.

Retailers and consumers who purchased jalapeno peppers should contact their supplier to determine if they have purchased any products included in the recall. For more information, customers may contact Agricola Zaragoza at 956-631-6405.

Source: “Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk,” US Food and Drug Administration Press Release, July 21, 2008.

On July 24, 2008, Kids II Inc. recalled about 19,000 Bright Starts Ring Rattles because the tip of the rattle’s antenna, which is attached to a bee figure, may detach, posing a choking hazard to small children.

Kids II received two reports of the tip of the antenna detaching, including one report that the purple ball was in the baby’s mouth, though no injuries have been reported.

The recalled rattle is a soft toy shaped as a bee, with a yellow head, ring-shaped green body, blue/green wings and purple/red antennas. Model number 8534 and date code PA8 are printed on a label sewn into the bee’s head.

Toy stores, mass merchandisers and other retail stores nationwide sold the recalled Bright Starts Ring Rattles from January 2008 through June 2008 for between $2 and $3.

Consumers are advised to immediately remove the recalled rattles away from small children and contact Kids II at 877-325-7056 to receive a free replacement. For more information, customers may also visit the company’s website.

Source: “Kids II recalls infant rattles due to choking hazard,” US Consumer Product Safety Commission Release #08-343, July 24, 2008.

On July 22, 2008, It’s My Binky recalled about 115,000 It’s My Binky’s Personalized Pacifiers because the button, ring handle and shield with nipple may detach, posing a choking hazard to infants. While the company has not received any reports of injuries, it has received two reports of the parts detaching.

Recalled It’s My Binky pacifiers have the word “Japlo” printed on the front of the shield. The recalled products were sold in blue, white and pink, and have various words or designs printed on the bottom of the pacifier.

Nordstrom and baby boutique retail stores nationwide, as well as itsmybinky.com, sold the recalled pacifiers from February 2006 through June 2008 for between $5 and $8.

Consumers are advised to immediately remove the pacifiers away from children and return them to the place of purchase, or to contact It’s My Binky at 888-689-9444 to receive a free replacement pacifier.

For more information, customers may also visit the company’s website, or email company representative Danielle Riiber.

Source: “It’s My Binky recalls personalized pacifiers due to choking hazard,” US Consumer Product Safety Commission Release #08-336, July 22, 2008.

On July 23, 2008, TTI Floor Care North America recalled about 987,000 Dirt Devil Vacuum Power Brush Attachment Tools after receiving 140 reports of incidents, including 12 reports of minor eye or skin injuries and one report of a thumb injury.

Plastic pieces inside of the recalled vacuum tool can break apart and be ejected, posing a laceration hazard to consumers. The recalled Dirt Devil Turbo Tool/Power Brush attachment was sold together with the following Dirt Devil vacuum models:

• Reaction Model (M110000, M110000HD, M110001B, M110002, M110003, M110006, M110008, M110008CA, M110009),
• Purpose for Pets (M140000, M140000CA),
• Envision Wide Glide (M086700WCA, M086710),
• Action Upright (M110020CAB),
• Ultra Swivel Glide (M086020),
• Swerve (M086030, M086030CA), and
• Royal Commercial (RY6100).

Vacuum tool accessories with date codes J7060 through J7365 and accessories that have a C-clip connector are the only ones included in the recall. Date codes are found on the bottom of the vacuum accessory.

The recalled Dirt Devil Vacuum Power Brush Attachment Tools are about 6.5 inches long and about 5 inches wide, and were sold in a variety of colors that match the color of the vacuum.

Mass merchandisers, home improvement stores and other retail stores nationwide sold the recalled TTI Floor Care North America vacuum attachment tools from April 2007 through April 2008 for between $60 and $170.

Consumers are advised to immediately stop using the recalled Dirt Devil Accessory Tool and contact TTI Floor Care North America at 800-245-2296 for a free repair kit. For more information, customers may also visit the company’s website.

Source: “Dirt Devil Vacuum Accessory Tools recalled due to laceration hazard,” US Consumer Product Safety Commission Release #08-339, July 23, 2008.

On July 23, 2008, Beef Packers, Inc. recalled about 1,560 pounds of beef cheek products because they have the potential to be contaminated with E. coli O157:H7, which could cause foodborne illness from E. coli.

Included in the recall are 30-pound boxes of “Cargill Meat Solutions Corporation, Beef Cheek Meat – SM BX.” The boxes of the recalled products have the establishment number “EST. 354” and a “PACKED ON” date of “07/02/08,” printed on the label.

Recalled beef cheek products were shipped to distributors on Modesto, Santa Rosa, Fresno and Vernon, California.

Consumers are advised to contact Beef Packers Inc.’s consumer line at 1-800-545-1679 with questions. For more information, customers may also “Ask Karen,” the Food Safety and Inspection Service (FSIS) virtual representative available 24 hours a day at AskKaren.gov. In addition, consumers may contact the United States Department of Agriculture’s Meat and Poultry Hotline at 1-888-674-6854.

Source: “California firm recalls beef cheek product due to possible E. coli O157:H7 contamination,” FSIS-Recall Release 024-2008, July 24, 2008.

On July 9, 2008, Salmolux Inc. recalled lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox because it may be contaminated with Listeria monocytogenes, which could cause foodborne illness from Listeria.

The recalled Alaskan Smoked Salmon was sold in 3-ounce blue packages and was distributed in Arizona, California, Nevada, Delaware, Florida, Georgia, Maryland, North Carolina, Pennsylvania, South Carolina, West Virginia and Virginia in Von’s retail outlets or in Food Lion.

The lot number (# 01418) is marked on the product’s rear white label that includes the name of the product, its ingredients and an expiration date.

While no illnesses have been reported, consuming food contaminated with Listeria monocytogenes may cause foodborne illness from Listeria.

Consumers who have purchased recalled Wild Alaskan Smoked Salmon Nova Lox are encouraged to return it to the place of purchase for a full refund. For more information, customers may also contact Salmolux Inc. at 253-874-2026, extension 214.

Source: “Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk,” US Food and Drug Administration Press Release, July 9, 2008.

On July 9, 2008, Lucky Green Trading, Inc. recalled Thai Basil due to its potential to be contaminated with Salmonella, which could cause foodborne illness from Salmonella. The recalled Thai Basil was distributed in retail stores and through direct delivery to customers in Southern California, Arizona and Nevada on June 30, 2008.

The recalled product was shipped in 14-pound cardboard cartons with 12 individual packages, which weigh about 1.2 pounds each. Exterior cartons were labeled with, “16 DE SEPTIEMBRE S/N SANTA ROSA TAPACHULA NAYARIT, C.P. 63737,” and “Thai Basil.” There was also an attached sticker with Airway Bill #027 1947 0861 written on it.

While no illnesses have been reported, consuming food contaminated with Salmonella may cause foodborne illness from Salmonella.

Lucky Green Trading has suspended distribution and importation of the recalled Thai Basil while the Food and Drug Administration (FDA) and the company continues to investigate.

Consumers who purchased basil should contact the place of purchase to determine if it is recalled Thai Basil. For more information, customers may also contact Lucky Green Trading at 714-554-9293.

Source: “Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk,” US Food and Drug Administration Press Release, July 9, 2008.

On July 2, 2008, Nissan North America, Inc. announced it was recalling about 169,202 2007 Nissan Sentra vehicles and 2008 Nissan Sentra vehicles because an irregularity in the Robert Bosch Master Cylinder may cause a gap in the groove contact area of the seal, which could result in brake fluid slowly leaking into the brake booster assembly.

This would cause the brake warning to illuminate and, if ignored, a brake circuit may not operate properly, increasing the risk of a catastrophic injury from a car accident.

Nissan dealers will inspect the Master Cylinder/Brake Booster Assembly and will replace it if a brake fluid leak is detected. Nissan owners may contact the company at 1-800-647-7261. For more information, customers may also contact the National Highway Traffic Safety Administration’s Vehicle Safety Hotline at 1-888-327-4236, or visit safercar.gov.

Source: National Highway Traffic Safety Administration Campaign ID Number 08V311000, July 2, 2008.

On June 24, 2008, Nordstrom Inc. recalled about 1,500 Nordstrom’s Cadence-Lea Girl’s Sandals and Nordstrom’s Trio-Lea Girl’s Sandals because flower embellishments on the sandals can detach, posing a choking hazard to young children.

Recalled girl’s sandals are leather and were sold in white, light green or silver in girls’ sizes 5 through 12. The brand “Nordstrom” is printed on the recalled sandals.

Nordstrom stores sold the recalled Cadence-Lea and Trio-Lea Girl’s Sandals from March 2008 through May 2008 for about $30. Consumers are advised to immediately remove the recalled girl’s sandals away from children and return them to any Nordstrom store for a refund.

For more information, customers may contact Nordstrom at 800-804-0806, or visit the company’s website

Source: “Nordstrom recalls girls’ sandals due to choking hazard,” US Consumer Product Safety Commission Release #08-311, June 24, 2008.

On June 27, 2008, E-Z-GO recalled about 16,500 RXV Golf Cars because the hip restraints on the cars can detach at the base, posing a fall hazard to consumers. The company received 20 reports of hip restraints breaking, including nine reports of broken bones and abrasions resulting from falls.

Included in the recall are electric and gasoline-powered Fleet RXV, Freedom RXV and RXV Shuttle 2+2 golf cars. Model names and the E-Z-GO logo are printed on the sides and front panel of the recalled vehicles. Serial numbers, ranging from 9300001 to 9300188 and 5000000 to 5021328, are printed on a plate attached to the steering column, as well as the front and rear frames.

Independent golf car dealers and E-Z-GO sold the recalled RXV Golf Cars nationwide from January 2008 through June 2008 for between $7,000 and $9,000.

Consumers are advised to contact the nearest E-Z-GO dealer to arrange for a free repair. For more information, customers may contact E-Z-GO at 800-774-3946, or visit the company’s website.

Source: “E-Z-GO recalls RXV golf cars due to fall hazard,” US Consumer Product Safety Commission Alert #08-591, June 27, 2008.

On June 26, 2008, Westminster Inc. recalled about 102,000 “Thunder Wolf” Remote Controlled Indoor Helicopters after receiving seven reports of overheating and/or melting of the helicopter. Included in the consumer reports were one report of flames and two reports of minor property damage.

The rechargeable battery located inside the recalled helicopter can overheat, which poses a fire/burn hazard to consumers.

The recalled “Thunder Wolf” Remote Controlled Indoor Helicopter is made of foam and plastic in various colors and is sold with a controller and a separate charger. The helicopter measures about 7 inches by 3 inches, and has “TW0996” printed on the tail of the helicopter. Helicopters that do not have the words “Made in China” stamped on the underside of the helicopter are the only helicopters included in the recall.

Retail stores nationwide sold the recalled Westminster helicopters from June 2007 through December 2007 for about $20.

Consumers are advised to immediately stop playing with the recalled “Thunder Wolf” Remote Controlled Indoor Helicopters and contact Westminster Inc. at 800-618-0023 for a refund. For more information, customers may also visit the company’s website or email the company.

Source: “Westminster Inc. recalls Remote-Controlled Helicopter Toys due to risk of fire,” US Consumer Product Safety Commission Release #08-315, June 26, 2008.

On July 11, 2008, American Welding & Tank LLC recalled about 11,000 Conversion Underground Propane Storage Tanks after receiving one report of two consumers sustaining first and second degree burns while attempting to light an outdoor fireplace.

To help alert customers to propane leaks, manufacturers added an odorant, but rust inside a propane tank may cause the odor to fade. This can cause consumers to be unable to detect the odor of propane if there is a leak, posing a fire/burn hazard to consumers.

Included in the recall are 120 gallon to 1,000 gallon Conversion Underground Propane Storage Tanks that were converted from above-ground to underground between January 2005 and April 2008.

Retail propane dealers sold the recalled propane storage tanks from January 2005 through April 2008. The retail propane company will perform the necessary repairs.

For more information, customers may contact American Welding & Tank at 866-614-0910, or visit the company’s website.

Source: “Propane Storage Tanks recalled by American Welding & Tank due to risk of gas leak; can pose fire and burn hazard,” US Consumer Product Safety Commission Alert #08-594, July 11, 2008.

On July 17, 2008, American Honda Motor Co. Inc. recalled about 42,000 2007 TRX 420 Rancher ATVs and 2008 TRX 420 Rancher ATVs because of a risk of personal injury to riders. If the ATVs’ rubber constant velocity (CV) boots get punctured or join, the joint may become contaminated. This could cause severe binding of the CV joints, resulting in a sudden loss of steering control.

The recalled Rancher ATVs, also known as the Honda FourTrax Rancher 4X4, are adult-sized vehicles designed for riders 16 years old or older. The ATVs were sold in red, black, olive and camouflage, with the Honda name and logo printed on the fuel tank. Model years are printed on a label on the frame behind the left front wheel, with the model name “Rancher” on a label at the left rear of the vehicle.

Honda ATV dealers nationwide sold the recalled TRX 420 Rancher ATVs from January 2007 through May 2008 for between $5,300 and $5,600. Consumers are advised to immediately stop using the recalled ATVs and contact any Honda ATV dealer to schedule a free repair.

For more information, customers may also contact Honda at 866-784-1870, or visit the company’s website.

Source: “All-Terrain Vehicles recalled by American Honda Motor Co. due to risk of loss of control hazard,” US Consumer Product Safety Commission Alert #08-595, July 17, 2008.

On July 10, 2008, Parragon Inc. recalled about 500,000 children’s necklaces with ballet shoes charms because solder on the charm may contain high lead levels, posing a lead poisoning hazard.

The recalled Parragon necklace is silver in color with a silver-colored ballet shoes and bow charm. The necklace was given with the purchase of a children’s book entitled, The Magical Ballet Slippers or Ballerina’s Magical Shoes, ISBN 1405411449. The UPC number 9781405411448 is printed on the back of the book, which was also sold in Spanish and in French.

Retail chains and independent bookstores nationwide sold the recalled children’s necklace with ballet shoes charms from January 2003 through June 2008 for about $7.

Consumers are advised to immediately remove the recalled necklaces away from children and contact Parragon at 888-480-2854 for instructions on returning the necklace. For more information, customers may also visit the company’s website.

Source: “Parragon Books recalls children’s necklaces due to risk of lead exposure,” US Consumer Product Safety Commission Release #08-326, July 10, 2008.

On July 17, 2008, Studio RTA recalled about 6,700 TV Stands because they do not meet industry stability standards, which poses a tip-over hazard to consumers.

Included in the recall are black or silver “Silhouette” TV stands with black frames and three glass shelves. Model numbers, which are printed on the packing and instruction sheet, included in the recall of Studio RTA TV stands are 403650 and 404191.

Shopko and Boscov’s stores nationwide sold the recalled Silhouette TV Stands from September 2007 through June 2008 for about $140.

Consumers are advised to immediately remove TVs from the TV Stands and contact Studio RTA at 888-309-0299 for a free repair kit. For more information, customers may also visit the company’s website.

Source: “Studio RTA recalls TV Stands due to TV tip-over hazard,” US Consumer Product Safety Commission Release #08-331, July 17, 2008.

On July 14, 2008, Nestlé Prepared Foods Company recalled about 199,417 pounds of frozen stuffed chicken sandwich products because they may contain pieces of plastic.

Included in the recall are 9-ounce boxes of Lean Pockets Spinach Artichoke Chicken, which holds two sandwiches. A “Best Before” date of “Nov 2009” is found printed on the side of each box, along with a package code beginning “8144 544646” and an establishment number “P7721A.”

The recalled Nestlé frozen chicken products were produced on May 23, 2008 and were distributed to retail stores nationwide. Nestlé initiated the recall after receiving consumer complaints, including reports of two injuries.

Customers may contact the Nestlé Consumer Services Center at 800-350-5016. Consumers can also “Ask Karen,” the Food Safety and Inspection Service (FSIS) virtual representative available 24 hours a day at AskKaren.gov. In addition, customers may use the United States Department of Agriculture (USDA) Meat and Poultry Hotline: 1-888-674-6854.

Source: “Kentucky firm recalls frozen stuffed chicken sandwiches that may contain pieces of plastic,” Recall Release FSIS-RC-023-2008, July 14, 2008.

On June 24, 2008, Nissan North America, Inc. recalled about 180,664 2005-2006 Nissan QX56 vehicles, 2005-2006 Nissan Armada vehicles, and **2005-2006 Nissan Titan vehicles because they may be equipped with an improperly sealed air conditioning condenser fan motor. This may allow excessive water intrusion and inadequate drainage of moisture, causing corrosion in the motor and possibly leading to overheating, posing a fire hazard.

To remedy the problem, Nissan dealers will install a “Thermal Protector Kit” and test the fan motor, replacing it if necessary.

Customers may contact Nissan at 1-800-647-7261. For more information, consumers may also contact the National Highway Traffic Safety Administration’s Vehicle Safety Hotline at 1-888-327-4236, or visit safercar.gov.

Source: National Highway Traffic Safety Administration Campaign ID Number 08V284000, June 24, 2008.

On July 10, 2008, F.A.F. Inc. recalled about 30,000 “Faded Glory” Lip Gloss, Locket and Bracelet Sets because the bracelet’s lobster claw clasp contains high lead levels, which could cause lead poisoning.

Three-piece sets are included in the recall, and they contain a rectangle-shaped lip gloss container, a heart-shaped locket necklace and a charm bracelet. The words “Faded Glory,” along with the model number and UPC code, are printed on the product’s hangtag.

The following are item descriptions, model numbers and UPC codes for products included in the recall:

• Frog Set: Model Number 6709-4250, UPC 72783357703,
• Monkey Set: Model Number 6709-4251, UPC 72783357704, and
• Cat Set: Model Number 6709-4252, UPC 72783357705.

Wal-Mart stores nationwide sold the recalled “Faded Glory” Lip Gloss, Locket and Bracelet Sets from May 2008 through June 2008 for about $6.

Consumers are advised to immediately remove the bracelets from children and return the set to any Wal-Mart store for a full refund. For more information, customers may contact F.A.F. Inc. at 800-949-3311, or visit the company’s website.

Source: “Lip Gloss and Jewelry Sets sold exclusively at Wal-Mart recalled by F.A.F. Inc. due to risk of lead exposure,” US Consumer Product Safety Commission Release #08-329, July 10, 2008.

On June 24, 2008, Miracle Recreation Equipment Company recalled about 1,400 Playground Tire Swings because the hanger clamp can fail, which can cause the tire swing to detach. This poses a fall hazard to children.

The company received three injury reports, including two reports of cuts requiring stitches and one report of a fractured foot.

Recalled Tire Swings consists of a tire that hangs from a swivel and three chains, and includes the following products and model numbers:

• Kids’ Choice Arch Tire Swing Sets, Model # 714-852,
• Kids’ Choice Arch Tire Swing Extension, Model # 714-852-X, and
• Kids’ Choice Arch Tire Swing Swivel Replacement, Model # 278.

Authorized dealers sold the recalled tire swings to schools, parks and municipalities nationwide from February 1995 through March 2008 for between $570 and $2,100.

Consumers are advised to immediately remove the tire swing, including the swivel, chains and tire, from the hanger clamp until a free repair kit is installed. For more information, customers should contact Miracle Recreation by calling 800-523-4202, by visiting their website, or by mailto:recalls@miraclerec.com the company.

Source: “Miracle Recreation Recalls Tire Swings Due to Fall Hazard,” US Consumer Product Safety Commission Release #08-587, June 24, 2008.

On July 3, 2008, The Kroger Co. expanded an earlier recall of ground beef products due to an ongoing investigation of a foodborne illness from E. coli outbreak. Included in the recall are ground beef products that were packaged in Styrofoam trays and wrapped in clear cellophane at the following Kroger establishments:

• Fred Meyer - Product with “Sell By” dates between “05/21/08” and “07/05/08,”
• QFC - Product with “Sell By” dates between “05/21/08” and “07/05/08,”
• Kroger stores (except in Georgia, South Carolina, Alabama, Knoxville, Tennessee, Virginia and West Virginia) - Product with “Sell By” dates between “05/21/08” and “07/03/08,”
• Kroger Mid-Atlantic division - Product with “Sell By” dates between “05/19/08” and “07/03/08,”
• Fry’s - “Sell By” dates between “05/21/08” and “07/03/08,”
• Ralph’s - Product with “Sell By” dates between “05/21/08” and “07/03/08,”
• Smith’s - Product with “Sell By” dates between “05/21/08” and “07/03/08,”
• Baker’s - Product with “Sell By” dates between “05/17/08” and “07/03/08,”
• King Soopers - Product with “Sell By” dates between “6/20/08” and “07/03/08,”
• City Market - Product with “Sell By” dates between “06/20/08” and “07/03/08,”
• Hilander - Product with “Sell By” dates between “05/21/08” and “07/03/08,”
• Owen’s - Product with “Sell By” dates between “05/21/08” and “07/03/08,”
• Pay Less - Product with “Sell By” dates between “05/21/08” and “07/03/08,”
• Scott’s - Product with “Sell By” dates between “05/21/08” and “07/03/08,”
• Dillons - Product with “Sell By” dates between “05/17/08” and “07/03/08,” and
• Gerbes - Product with “Sell By” dates between “05/17/08” and “07/03/08.”

Also included in the recall are 16-ounce packages of “Private Selection Natural Ground Beef,” with “Sell By” dates between “07/11/08” and “07/21/08.” This recalled product was distributed to Kroger retail establishments, Dillons, Fred Meyer, Baker’s, Smith’s and Fry’s stores.

Consumers are urged to check refrigerators and freezers to determine if they own a recalled Kroger ground beef product, and, if they do, to throw it away or return it for a refund.

Consumers may contact the Kroger Consumer Hotline at 800-632-6900. For more information, customers may also “AskKaren,” the Food Safety and Inspection Service virtual representative available 24 hours a day at AskKaren.gov. In addition, the United States Department of Agriculture Hotline is available at 1-888-674-6854.

Source: “Ohio firm expands recall of ground beef products due to possible E. coli O157:H7 contamination,” Food Safety and Inspection Service Release R01-2008, July 3, 2008.

On July 2, 2008, RadioShack Corp. recalled about 160,000 13.8V DC Power Supplies because they were wired incorrectly, posing an electrocution hazard and a fire/burn hazard to consumers.

Included in the recall are power supplies with catalog numbers 22-507 and 22-508, and with date codes from 08A04 through 01A08. Both numbers can be found on the back of the recalled power supply.

RadioShack stores nationwide sold the recalled 13.8V DC Power Supplies from October 2004 through January 2008 for between $50 and $85.

Consumers are advised to immediately unplug the recalled RadioShack power supply and take it to any RadioShack store for a free repair. For more information, customers may contact RadioShack at 800-843-7422, or visit the company’s website.

Source: “RadioShack recalls power supplies due to electrocution and fire hazards,” US Consumer Product Safety Commission Release #08-319, July 2, 2008.

On June 27, 2008, Hewlett-Packard recalled about 367,000 HP Fax 1010 Machines and HP Fax 1010xi Machines after receiving three reports of overheating, including two reports of minor property damage. The recalled Hewlett-Packard fax machines are a fire/burn hazard to consumers.

The HP Fax 1010 Machines and HP Fax 1010xi Machines included in the recall are models manufactured from November 2002 through September 2004, with the HP logo and the model name and number located on the front of the fax machine.

Electronic, computer and camera stores nationwide sold the recalled Hewlett-Packard fax machines, in addition to Web retailers, from November 2002 through December 2004 for between $130 and $150.

Consumers are advised to immediately disconnect the recalled Hewlett-Packard fax machines from the electrical power source and contact Hewlett-Packard at 888-654-9296 for a rebate. For more information, customers may also visit the company’s website.

Source: “Hewlett-Packard Co. recalls fax machines due to fire hazard,” US Consumer Product Safety Commission Release #08-313, June 27, 2008.

On June 26, 2008, Stanley Furniture Company Inc. recalled about 1,200 2nd Nature Built to Grow Cribs because they could fail to meet a federal safety standard for crib dimensions, and may pose an entrapment hazard to infants.

The mattresses in the recalled cribs, when the mattress support is in the middle setting, may create a space between the mattress and the crib that could be too wide.

Included in the recall are 2nd Nature Built to Grow Cribs with model number 353-14-220. Located on the headboard are the model number and the serial numbers. The following serial numbers are included in the recall:

• 353-14-220-L-01,
• 353-14-220-L-02,
• 353-14-220-L-03,
• 353-14-220-L-04,
• 353-14-220-L-05,
• 353-14-220-L-06,
• 353-14-220-L-07,
• 353-14-220-L-08,
• 353-14-220-L-101, and
• 353-14-220-L-103.

Cribs sold after December 2007 are not included in the Stanley Furniture Company recall.

Department stores and furniture stores sold the recalled Stanley Furniture Company cribs from March 2006 through December 2007 for about $1,100.

Consumers are advised to immediately stop using the recalled crib in the middle mattress setting. Customers may contact Stanley Furniture at 888-839-6822 to receive a free replacement crib headboard if it is included in the recall. For more information, consumers may visit the company’s website.

Source: “Stanley Furniture recalls cribs due to entrapment hazard,” US Consumer Product Safety Commission Release #08-314, June 26, 2008.

On June 19, 2008, Mitsubishi Motors North America Inc. reported a recall of 73,000 2004 Mitsubishi Galant vehicles and 2005 Mitsubishi Galant vehicles because the ignition key interlock cable may allow the ignition key to be removed from the ignition switch when the gearshift is not in the park position. If the driver does not shift to park before removing the key and fails to engage the parking brake, the vehicle could roll, causing catastrophic injury from a car accident.

Mitsubishi dealers said they will inspect and correct the recalled Galant vehicles. Owners may contact Mitsubishi at 1-888-648-7820.

For more information, customers may also contact the National Highway Traffic Safety Administration’s Vehicle Safety Hotline at 1-888-327-4236, or visit safercar.gov.

Source: National Highway Traffic Safety Administration Campaign ID Number 08V276000, June 19, 2008.

On June 24, 2008, Dollar Tree, Inc. recalled about 470,000 Crafters Square Hot Melt Mini Glue Guns because they can short circuit, causing the gun to smoke and posing a fire/burn hazard to consumers. Dollar Tree initiated the recall after receiving four reports of the glue guns short circuiting, though no injuries have been reported.

Included in the recall are Crafters Square Hot Melt Mini Glue Guns with product number “939701,” which is found on the packaging of the glue gun. The gun itself is black with an orange trigger and is about 4.5 inches long from the back of the gun to the tip. The words “Crafters Square” are printed on the packaging, and “DS-010 Glue Gun” is written in raised letters on the handle of the gun.

Dollar Tree stores, as well as Dollar Bill$, Dollar Express, Greenbacks, Only One $1, and Deal$ stores, sold the recalled Crafters Square Hot Melt Mini Glue Gun from December 2007 through March 2008 for about $1.

Consumers are advised to immediately stop using the recalled glue guns and return them to the place of purchase for a full refund. For more information, customers may contact Dollar Tree Stores at 800-876-8077, or visit the company’s website.

Source: “Dollar Tree Recalls Glue Guns Due to Fire Hazard,” US Consumer Product Safety Commission Release #08-310, June 24, 2008.

On June 13, 2008, Buell Motorcycle Co. recalled about 1,579 2008 Buell 1125R motorcycles because a lack of lubrication can cause 5th gear galling, which can result in a rear wheel lock-up. This can cause a catastrophic injury from a motorcycle accident.

Dealers will inspect and repair the recalled Buell motorcycles. Owners may contact Buell Motorcycles at 1-414-343-8400. For more information, customers may also contact the National Highway Traffic Safety Administration’s Vehicle Safety Hotline at 1-888-327-4236, or visit safercar.gov.

Source: National Highway Traffic Safety Administration Campaign ID Number 08V267000, June 13, 2008.

On June 24, 2008, Arctic Cat Inc. recalled about 6,000 2008 Arctic Cat 50cc All-Terrain Vehicles (ATVs) and 2008 Arctic Cat 90cc All-Terrain Vehicles (ATVs) because the speed controller may fail to return to the idle position when the throttle lever is released, which could result in loss of vehicle control and personal injury to the rider.

Both 2008 model 50cc vehicles and 90cc vehicles are included in the recall, and have the following model and model numbers:

• 2008 DVX 50 Black/Red, Model Number A2008KSA2BUSD,
• 2008 DVX 50 Black/Lime, Model Number A2008KSA2BUSE,
• 2008 DVX 50 Pink, Model Number A2008KSA2BUST,
• 2008 DVX 90-California-Black/Red, Model Number A2008KSB2BCAD,
• 2008 DVX 90-California-Black/Lime, Model Number A2008KSB2BCAE,
• 2008 DVX 90-California-Pink, Model Number A2008KSB2BCAT,
• 2008 DVX 90 Black/Red, Model Number A2008KSB2BUSD,
• 2008 DVX 90 Black/Lime, Model Number A2008KSB2BUSE,
• 2008 DVX 90 Pink, Model Number A2008KSB2BUST,
• 2008 50 2X4 Auto Green, Model Number A2008KUA2BUSG,
• 2008 50 2X4 Auto Red, Model Number A2008KUA2BUSR,
• 2008 50 2X4 Auto Pink, Model Number A2008KUA2BUST,
• 2008 90 2X4 Auto-California-Green, Model Number A2008KUB2BCAG,
• 2008 90 2X4 Auto-California-Red, Model Number A2008KUB2BCAR,
• 2008 90 2X4 Auto-California-Pink, Model Number A2008KUB2BCAT,
• 2008 90 2X4 Auto Green, Model Number A2008KUB2BUSG,
• 2008 90 2X4 Auto Red, Model Number A2008KUB2BUSR, and
• 2008 90 2X4 Auto Pink, Model Number A2008KUB2BUST.

Arctic Cat dealerships sold the recalled 2008 Arctic Cat 50cc ATVs and 2008 Arctic Cat 90cc ATVs from July 2007 through June 2008 for between $1,800 and $2,400.

Consumers are advised to immediately stop using the recalled ATV and contact their local dealer for a free repair. For more information, customers may contact Arctic Cat at 800-279-6851, or visit the company’s website.

Source: “Arctic Cat Recalls Model Year 2008 50cc and 90cc Youth Model ATVs,” US Consumer Product Safety Commission Release #08-588, June 24, 2008.

On June 23, 2008, Fresca Italia expanded its recall of Burrata, a type of cheese, after tests found additional lots of the product also tested positive for Listeria monocytogenes, which could cause foodborne illness from Listeria.

The recalled Burrata was distributed in the San Francisco Bay Area and Southern California in retail stores and restaurants. The Burrata included in the recall weighs about 8.8 oz and is packaged in a white and green plastic wrapper with “Caseificio Voglie di Latte,” and “Burrata” printed on the wrapper.

All lot codes and expiration dates from the manufacturer, Caseificio Voglie di Latte, are included in the recall. The following are the quantities that were distributed:

• 606 lbs with the Lot Code 24/5/2008,
• 661 lbs with the Lot Code 31/5/2008, and
• 490 lbs with the Lot Code 07/06/2008.

Consumers who have any Caseificio Voglie di Latte Burrata should return it to the place of purchase for a full refund. For more information, customers may contact Fresca Italia at 415-468-9800.

Source: “Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk,” US Food and Drug Administration Press Release, June 23, 2008.

On June 24, 2008, Jardine Enterprises recalled about 320,000 Jardine Cribs after receiving 42 reports of crib slats and spindles breaking, including four reports of children becoming entrapped in the space created by the broken slat or spindle. Two of the children who became entrapped suffered from abrasions and bruising.

The cribs that pose a strangulation hazard and entrapment hazard are wooden cribs in various styles and finishes. Model numbers can be found on the inside of the bottom rail of the recalled crib’s headboard or footboard.

KidsWorld, Geoffrey Stores, Toyr “R” Us and Babies “R” Us stores as well as babiesrus.com sold the recalled Jardine Cribs nationwide from January 2002 through May 2008 for between $150 and $300. One recalled model, the Mahogany Positano Lifetime Crib with model number 0309K00, was sold for $450.

Consumers are advised to immediately stop using the recalled Jardine Cribs and contact Jardine at 800-646-4106 for credit towards the purchase of a new crib. For more information, customers may also visit the company’s website.

Source: “Jardine Cribs Sold by Babies”R”Us Recalled Due to Entrapment and Strangulation Hazard,” US Consumer Product Safety Commission Release #08-312, June 24, 2008.

On June 19, 2008, Wal-Mart Stores Inc. recalled about 39,000 “Hip Charm” Key Chains, expanding an April 2008 recall, due to a lead poisoning hazard. Wal-Mart previously recalled 12,000 key chains, also because of high lead levels.

While no injuries have been reported, the Illinois Attorney General reported in April 2008 that the previously recalled key chain was found in the home of a 9-month-hold child who was observed mouthing the key chain, and was later found to have high blood levels of lead.

The recalled Wal-Mart key chains have button, clover, leaf and heart charms that hang from a silver-colored chain. Printed on the product’s packaging are the words “Hip charm” and the following UPC numbers:

• 03156811032,
• 03156811029,
• 03156811019,
• 03156811016,
• 03156811018,
• 03156811028, and
• 03156811030.

Recalled “Hip Charm” Key Chains were sold at Wal-Mart stores nationwide from April 2005 through June 2080 for between $.50 and $6. Consumers who own a recalled key chain should not allow children to handle it, and should return it to any Wal-Mart store for a refund.

For more information, customers may contact Wal-Mart at 800-925-6278, or visit the company’s website.

Source: “Wal-Mart recalls additional charm key chains due to risk of lead exposure,” US Consumer Product Safety Commission Release #08-307, June 19, 2008.

Inspectors with the Food and Drug Administration (FDA) are searching farms in Florida and Mexico in attempts to find the source of tomatoes contaminated with salmonella that have sickened 552 people. The focus of the investigation will be on big packing houses or distribution warehouses.

The earliest consumers who reported foodborne illness from Salmonella got sick on April 10, 2008, and the latest was on June 5, 2008. Thirty states have reported sick residents, with at least 48 consumers being hospitalized.

The agency speculated that parts of Mexico and Florida are the most probable sources of the Salmonella contamination because they were supplying a majority of the nation’s tomatoes at the time of the outbreak.

Meanwhile, consumers are urged to avoid eating raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries the FDA has cleared of suspicion. For an updated list, customers can visit the FDA’s website.

Source: “Tainted tomato cases reach 552,” MSNBC.com, June 20, 2008.

On June 18, 2008, Tucker Rocky Distribution recalled about 12,000 Pro Taper Clamp Kits Used with Off-Road Motorcycles because the bolts included in the kits can break under extreme force if installed incorrectly. This can cause the handlebars to separate, which could cause personal injury to the rider.

While no injuries have been reported, there have been seven reports of bolts breaking. The recalled Pro Taper Clamp Kits are aftermarket accessories for off-road motorcycles. The kits included in the recall are the Upper Triple Clamp Kit, Complete Triple Clamp Kit, Handlebar Clamp Kit (Universal Solid Mount Kit and Universal Rubber Mount Kit), and Replacement Bolt Kit.

Part numbers for the Upper Triple Clamp Kit included in the recall are:

• 02-2824, 02-2825, 02-2826, 02-2827, 02-2828, 02-2829, 02-2843, 02-2844, 02-2845, 02-2846, 02-2849, and 02-2851.

Part Numbers for the Complete Triple Clamp Kit included in the recall are:

• 02-2830, 02-2831, 02-2832, 02-2833, 02-2834, 02-2839, 02-2840, 02-2847, 02-2848, 02-2850, 02-2852, 02-2853, 02-2854, and 02-2855.

Part numbers for the Handlebar Clamp Kit included in the recall are:

• 02-2821 and 02-2822

Part numbers for the Replacement Bolt Kit included in the recall are:

• 02-2855 and 02-2886.

Recalled Tucker Rocky clamp kits were sold at motorcycle dealerships nationwide from October 2007 through March 2008 for between $5 and $440.

Consumers are advised to immediately stop riding off-road motorcycles equipped with the recalled kits and contact Tucker Rocky at 866-217-7750 for free replacement bolts. For more information, customers may also visit the company’s website.

Source: “Tucker Rocky Recalls Off-Road Motorcycle Clamp Kits; Bolts Can Break Causing Handlebars to Separate During a Crash and Cause Serious Injury,” US Consumer Product Safety Commission Release #08-306, June 18, 2008.

On June 17, 2008, Tipu’s Tiger Chai Inc. recalled Tipu’s Tiger Chai Concentrate because it may be contaminated with Clostridium botulinum, a bacterium that may cause botulism. Botulism is a potentially fatal form of food poisoning.

The recalled Tipu’s Tiger Chai Concentrate was distributed mainly to stores and coffee kiosks in western Montana, and to one café in Prescott, Arizona. It was distributed in plastic half-gallon units labeled with the product’s name. “Refrigerate after opening,” along with dates of 09-23/09 through 05/22/10 are printed on the lid or neck of the bottle.

Consumers who purchased the recalled Tipu’s Tiger Chai Concentrate should return it to the place of purchase for a refund. For more information, customers may also contact the company at 1-888-506-2424.

Source: “Tipu’s Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk,” US Food and Drug Administration Press Release, June 17, 2008.

On June 12, 2008, Pacific Cycle Inc. recalled about 15,000 Playsafe Spinning Quad Merry-Go-Rounds because the inner bearing can fail and cause the seat assembly to suddenly drop to the ground. This poses a fall hazard to young children. The company received one report of a consumer injury, in which a child fell and suffered abrasions.

The recalled Playsafe Spinning Quad Merry-Go-Round has four plastic yellow seats with black and silver metal bars. They were sold at Toys R Us stores nationwide from January 2008 through March 2008 for between $80 and $100.

Consumers who own a recalled Pacific Cycle Merry-Go-Round should immediately take it away from children and return it to Toys R Us for a refund. Customers may also contact Pacific Cycle at 877-564-2261 to receive a free retrofit kit. For more information, consumers may also visit the company’s website.

Source: “Children’s Merry-Go-Rounds Sold Exclusively at Toys R Us Recalled by Pacific Cycle Due to Fall Hazard,” US Consumer Product Safety Commission Release #08-305, June 12, 2008.