Recalls in November 2012

Tegol, Inc. is recalling nearly 4,600 motorcycle helmets, models AX-30010 Outlaw Carbon Tech Glossy, AX-30020 Outlaw Carbon Tech Matte, and AX-30030 Outlaw Carbon Tech Red, all sizes.

The helmets fail to conform to the impact attenuation, penetration, labeling and retention requirements of Federal Motor Vehicle Safety Standard No. 218, "Motorcycle Helmets."

By wearing a noncompliant helmet, the user may not be adequately protected in the event of a crash, increasing the risk of personal injury.

Tegol will notify owners and will either replace any noncompliant helmet or offer a full refund. The manufacturer has not yet provided a remedy schedule.

Owners may contact Tegol's recall Hotline toll-free at 1-866-371-0281.

G-U Hardware of Newport News, VA, is recalling about 5,000 window fittings: tilt-turn stay arms and side-hung sash hinges.

The window fittings can break, causing the window to fall, posing an injury hazard to consumers. The company has received two reports of windows falling, including one report of a broken thumb.

This recall involves tilt-turn stay arm and side-hung sash hinge adjustable window fittings. They are used to attach a window to a frame and primarily sold for use in commercial buildings. The fittings have clamps, locking pins and stainless steel springs. “G-U” and the component number are stamped at the ends of the fitting.

The recalled G-U Hardware window fittings have the following model names, and model and component numbers:

The fittings, manufactured in Turkey, were sold by hardware wholesalers and window manufacturers nationwide from October 2002 to December 2011 for between $7 and $26.

Consumers may contact G-U Hardware toll-free at (855) 355-8810 to arrange for the free replacement and installation of new window fittings.

Britax is recalling 55,455 convertible child restraints, models Boulevard 70 G3, Advocate 70 G3, and Pavilion 70 G3, Model Numbers:

• E9LJ91A, E9LJ91M, E9LJ91S, E9LJ92E, E9LJ93P, E9LJ93S, E9LK91A, E9LK31A, E9LK31Q, E9LK32D, E9LK32Z, E9LK33Q, E9LL11A, E9LL11Q, E9LL12D, E9LL12Z, E9LG81A, E9LG83N, E9LG83P, E9LG83X, E9LG83Y, E9LL21A, E9LL23P, E9LL23Y, manufactured from June 2012 through August 2012.

These seats were manufactured with a softer chest pad material that may be bitten or chewed into pieces by a child using the seat. If the child bites off a piece of the softer pad, it could be a choking hazard, resulting in injury or death.

Britax will provide owners with replacement HUGS pads that are made from a firmer material and instructions on how to replace the pads free of charge.

Owners may remove the HUGS pads and continue using the seat until replacement pads are received. The safety recall is expected to begin shortly.

Owners may contact Britax Customer Service Department at 1-888-427-4829 with questions or to request replacement pads in the event their restraint is not already registered with Britax.

J.P. Boden & Co. Ltd., of the United Kingdom is recalling about 1,130 pairs of children's pajamas.

The garments fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries to children. No incidents or injuries have been reported.

The recalled products are 100 percent cotton pajamas for children 1.5 (18 months) to 14 years old. The brand name "Mini Boden" appears on a label attached to the back of the neck of the tops and the center of the back of the waist on the bottoms and on the packaging.

Each pack contains two long-sleeved tops and two bottoms in one of the following color schemes: black, white and blue with motorcycles print; white, blue and pink with rocket and stars print; or a light blue, blue and green with cars print. The garments were sold as pajamas.

The pajamas, manufactured in Turkey, were sold exclusively at Bodenusa.com from July 21, 2012 to September 17, 2012 for about $48.

Consumers should immediately stop using the pajamas and contact Boden for a full refund, exchange or merchandise credit.

Consumers may contact: J.P. Boden Services Inc. toll-free at (866) 206-9508, from 8 a.m. to 11 p.m. ET daily.

Focus Products of Lincolnshire, IL, is recalling Cocoa Latte Hot Drink Makers because a small bushing inside the container has the potential to leach lead. To date, the company has received no notice of any consumer complaints. However, the company’s independent testing revealed the potential problem.

The machines were sold under the following makes and model numbers:

• West Bend -- 65032
• Back to Basics -- CM300BK, CM300BKL, CM300BLSS, CM300BR, CM300BRBRL CM300BRL, CM300W

The only affected products are the Cocoa Latte Hot Drink Makers, makes and model numbers listed above. The Cocoa Grande Hot Drink Maker is NOT affected by this recall.

The affected products, which shipped nationwide from 2004 through October 12, 2012, come in a variety of colors with transparent pitchers, and were sold primarily in the United States through various retailers such as Bed Bath & Beyond, through various e-retailers such as Amazon.com and through Focus Products’ online store.

Consumers in possession of a Cocoa Latte Hot Drink Maker should contact Focus Products’ Call Center at 1-888-943-5202.

American Honda Motor of Torrance, CA, is recalling about 150,600 portable generators.

The generator’s fuel hose can leak, posing fire and burn hazards. Honda is aware of four incidents of fuel leaks. No fires or injuries have been reported.

This recall involves Honda gasoline-powered portable generators with model number EU2000i and serial numbers EAAJ-2260273 through EAAJ-2485025. The generators are black and red in color or have a camouflage design. They measure about 20 inches long by 11 ½ inches wide by 16 ½ inches tall. “

Honda,” “EU converter” and the model number 2000i are printed on the side of the generator. “Companion” is printed on the side of some EU2000i models. The serial number is located on the lower right side, rear corner of the generator.

The generators, made in Japan, were sold at Honda Power Equipment dealers, Camping World, Gander Mountain, Grainger, Hertz Rental, John Deere, National Pump & Compressor, Northern Tool, Scheels Sporting, Sportsman’s Warehouse, Sunbelt Rentals, True Value, United Rentals, White Cap and Wholesale Sports store nationwide and online from October 2011 through September 2012 for between $1,150 and $1,400.

Consumers should immediately stop using the recalled generators and contact the nearest Honda Power Equipment dealer to schedule a free inspection and repair.

Consumers can contact American Honda toll-free (888) 888-3139, 8:30 a.m. to 5 p.m. ET Monday through Friday.

Does it seem like we're hearing about some kind of food call every day? Actually, it's worse than that.

Food recalls occurred at an average rate of four a day in the third quarter of of this year as documented by U.S. Food and Drug Administration (FDA) enforcement reports. According to quarterly ExpertRECALL Index, this affected nearly 8.5 million units of food and beverages -- reflecting a 57 percent increase from the previous quarter.

Not just food affected

The pharmaceutical and medical device industries also recorded sharp increases in recall activity, accounting for the most events recorded for each industry in more than two years. While the number of documented drug recalls more than doubled in the third quarter, they affected nearly 16.2 million units, or about a million fewer units when compared to the second quarter.

The seventy percent increase in medical device recall activity also impacted fewer units than affected by recalls documented during the second quarter, dropping from 123.5 million units in the second quarter to 26.5 million in the third.

"The number of recalls we saw during the third quarter is troubling," said Mike Rozembajgier, vice president of recalls at Stericycle ExpertRECALL  , a firm that tracks consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. "But as we enter the holiday season, it's even more worrisome to know that nearly one-quarter of food and beverage companies that faced a recall in the third quarter had more than one event. As consumers are bombarded with advertisements and messages from manufacturers and retailers during the holiday season, it will be much more difficult for companies to cut through the clutter and connect with consumers on recalls. This is why both of these groups need to do their part to ensure that the food served during holiday parties to family and friends is safe."

Multiple events

The ExpertRECALL Index also found that more than one-third of pharmaceutical companies named in third-quarter Enforcement Reports were affected by more than one recall. This is the highest percentage of repeat violations by pharmaceutical companies in at least the last nine quarters.

Compounding pharmacies, which have recently made headlines due to a recent deadly outbreak of fungal meningitis, saw a marked increase in recall activity with one specialty laboratory being involved in 81 recalls.

"Questions have been raised recently about whether compounding pharmacies are regulated enough to protect consumers," said Rozembajgier. "While I cannot speak to the reason for each recall, or for the FDA, state pharmacy boards or laboratories involved, the trend this data suggests is alarming because so many products meant to help patients are being discovered as potentially harmful or even deadly."

"We now have a window into the operations of one large-scale compounding pharmacy, and the view is troubling, both in terms of the quantity and quality of compounded products in the commercial system," said Hogan Lovells Partner David M. Fox, who served as a senior FDA lawyer from 1994 to 2000. "We can now expect to see more recalls from commercial compounders in response to increased regulatory oversight and legal scrutiny."

Consumer product recalls dip

While recalls of consumer products declined slightly, the number of affected units rose from 7.5 million in the second quarter to 12 million in the third quarter. Concerns related to structural collapses were the leading cause of recalls followed by laceration risks.

Recalls of child nursery and equipment remained steady when compared with the second quarter, while recalls of toys slightly increased. The primary cause of children's and infant product recalls were risks that a child could fall out of the product.

Ever since a study showed bisphenol A (BPA), a major molecule used in the plastic industry, was an endocrine disruptor that could exert negative effects on human health, it has been the focus of even more health studies.

The latest, by researchers in France, has found that an unborn child exposed to BPA can be at increased risk of lowered thyroid function. The findings are based on a study of newborn sheep.

Hypothyroidism is characterized by poor mental and physical performance in human adults and in children can result in cognitive impairment and failure to grow normally.

A new direction

The French study is actually a departure from more recent investigations, that have focused on reproductive functions. It points to evidence that BPA might have negative effects on other endocrine systems including thyroid function.

The current study used sheep, which researchers said was a relevant model for human pregnancy and thyroid regulation and ontogeny. It analyzed the internal exposures of the fetuses and their mothers to BPA and determined to what extent those exposures may be associated with thyroid disruption.

“Our study is the first to show that BPA can alter thyroid function of pregnant animals and their offspring in a long-gestation species with similar regulation of thyroid function as humans,” said Catherine Viguié, PhD, of Toxalim, Research Centre in Food Toxicology in Toulouse, France and lead author of the study.

Further study

Because of the potential consequences of maternal/fetal thyroid disruption on neural and cognitive development, Viguié thinks her study warrants the need for further investigations on the effect of BPA on thyroid function.

Though BPA once was in nearly every kind of plastic container, it's being found in fewer these days. In the wake of studies raising health questions, many manufacturers have eliminated their use of the substance, even though the food industry continues to back it.

Most recently many beverage companies have begun using plastic bottles made without BPA, which is a hardening agent. Other manufacturers have also removed it from many brands of infant formula bottles.

Previous research

Most of the recent studies point to BPA’s ability to interfere with the body’s hormone system, potentially leading to a variety of health problems, including damage to the reproductive system and the brain, particularly in children. Eleven states have banned the chemical’s use in certain products, typically baby bottles and other children’s goods; Canada, China and the European Union have similar restrictions.

An industry group, the American Chemistry Council, says BPA has been used safely for decades and there is no evidence that it causes harm as it is currently used. A key component of many plastic products, BPA is found in everything from the lining of food cans to the paper used in store receipts.

Frito-Lay is recalling Grandma's Peanut Butter Sandwich Crème cookies and Grandma's Peanut Butter Mini Sandwich Crème cookies because they contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk or egg run the risk of a serious or life threatening allergic reaction if they consume these products.

No other Grandma's cookies products or flavors are affected and no complaint or illness has been reported to date.

The products are sold in retail stores nationwide. The affected packages are:

• 3.025 oz. packages of Grandma's Peanut Butter Sandwich Crème cookies that have a sell-by date of March 12, 2013 or earlier and UPC code of 28400-00153; and
• 1.71 oz. Grandma's Peanut Butter Mini Sandwich Crème cookies that have a sell-by date of May 21, 2013 or earlier and UPC code of 28400-00901.

The sell-by date is located on the front of the package.

The recall was initiated after it was discovered the products did not list the presence of possible allergens that are included in an artificial butter flavor ingredient.

Consumers with any product noted above can return it to the retailer for a full refund, or contact Frito-Lay Consumer Relations at 1- 877-650-3479.

Fresh Express Incorporated is recalling a limited quantity of Fresh Express Spinach with a Use-by Date of November 7 and Product Code of S299B25 due to a possible health risk from Salmonella.

No illnesses or consumer complaints have been reported at this time and no other Fresh Express products are subject to this recall.

The recall notification is being issued due to an isolated instance in which a random sample yielded a positive result for Salmonella under U.S. Department of Agriculture's random sample testing program.

Fresh Express customer service representatives are already contacting relevant retailers to confirm the recalled product has been removed from store shelves and inventories and that none is available for consumer purchase.

The recalled salads were distributed primarily in the Western region of the U.S.

Consumers who may have purchased the recalled salad are urged not to eat it, but to throw it out instead. Fresh Express is offering a full refund.

Consumers with questions or who would like to a refund may call the Fresh Express Consumer Response Center at (800) 242-5472 between 7 a.m. to 6 p.m. Eastern Time.