CSI, USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10% Benzoyl Peroxide Acne Cream with the names DG Maximum Strength Acne Medicated Gel (sold at Dollar General), Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication (sold at Kroger), and Equate: Medicated Acne Gel (sold at Wal-Mart). These products are being recalled because samples of the products were found to contain bacteria identified as Burkholderia Cepacia, formerly known as Pseudomonas Cepacia. After conducting a thorough assessment, the company concluded that the risk of illness in healthy individuals following use of this product is very low. However, there could be an increased health risk of infections for individuals with cuts, scrapes, rashes or other compromised skin conditions or those with weakened or suppressed immune systems.

ETHEX Corporation announced the recall of specific lots of certain generic products that it markets due to the possibility of oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs. Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure. The lots involved in the recall were all shipped prior to May 22, 2008 and are Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011.

ETHEX Corporation announced a voluntarily recall of generic non-branded products that it markets due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs. Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure. The lots involved in the recall were all shipped prior to May 22, 2008 and are Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009 and Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009.

ETHEX Corporation announced a voluntarily recall of generic /non-branded Morphine Sulfate Immediate Release tablets. They have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs. Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure. The lots involved in the recall were all shipped prior to May 22, 2008 and are Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010, Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011, and Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011.

ETHEX Corporation announced that it voluntarily recalled generic /non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs. Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure. The lots involved in the recall were all shipped prior to May 22, 2008 and are Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011, Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011, and Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011.

The U.S. Food and Drug Administration notified health care professionals and patients that Tyco Healthcare Group LP (Covidien) recalled one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. The recall applies to Lot Number 813900, ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin. Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall. These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product.

The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk. Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Animals can be carriers with no visible symptoms and can potentially infect other animals or humans.

BFNT HAS RECALLED 184 FIRESTONE BRAND FS400 TIRES, SIZE 315/80R22.5 LOAD RANGE L, COMMERCIAL TRUCK TIRES MANUFACTURED BETWEEN JUNE 15 AND JUNE 28, 2008. THESE TIRES WERE NOT BRANDED WITH THE MAXIMUM SPEED LIMIT RATE WHICH DOES NOT CONFORM TO THE MARKING REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 119, NEW PNEUMATIC TIRES FOR MOTOR VEHICLES WITH A GVWR OF MORE THAN 4,536 KILOGRAMS (10,000 POUNDS) AND MOTORCYCLES.

KIA IS RECALLING 6,680 MY 2008-2009 RONDO LX AND EX VEHICLES EQUIPPED WITH A 2.4 LITER ENGINE. THE FUEL PUMP MAY NOT OPERATE PROPERLY RESULTING IN NOT ENOUGH FUEL GETTING TO THE ENGINE. POOR ENGINE STARTING, ENGINE HESITATION, AND OTHER IMPAIRMENT MAY RESULT, AND THE CHECK ENGINE LIGHT MAY ILLUMINATE. UNUSUALLY SEVERE IMPAIRMENT WHILE DRIVING COULD EXPOSE THE DRIVER TO THE RISK OF A CRASH.

Toy Boats Recalled by Buzz's Boatyard Due to Violation of Lead Paint Standard. Hazard: The paint on the recalled toy boats contains an excess level of lead, violating the federal lead paint standard. Incidents/Injuries: None reported. Description: This recall involves two models of tin Pop Pop toy boats. Models included in the recall are the 13-inch “Titanic” and the “Hut” Pop Pop boats.

JFC International, Inc. Issues Allergy Alert on Undeclared Sulfite in ''Kyosai Sengiri Daikon'' Dried Radish. Recalling all products of Kyosai Sengiri Daikon (40/3.50z) due to the present of undeclared sulfite. People who have an allergy or severe sensitivity to sulfite run the risk of life-threatening allergic reaction if they consume this product.

GM IS RECALLING 79 MY 2009 CHEVROLET IMPALA VEHICLES. SOME OF THESE VEHICLES HAVE A PASSENGER-SIDE FRONT AIR BAG INFLATOR THAT COULD FRACTURE AT AN INFLATOR TUBE DURING A DEPLOYMENT. DURING A PASSENGER-SIDE AIR BAG DEPLOYMENT, PIECES OF THE INFLATOR TUBE COULD STRIKE AND INJURY VEHICLE OCCUPANTS AND THE AIR BAG CUSHION WOULD NOT INFLATE FULLY, REDUCING THE CAPABILITY OF THE BAG TO PROTECT THE PASSENGER.

Gas Vent Dampers Recalled by Effikal Due to Carbon Monoxide Hazard . The automatic gas vent damper could fail, and if the blocked vent switch does not activate, the vent could leak carbon monoxide (CO). This poses a risk of CO poisoning to consumers.

CHICCO USA, INC. IS RECALLING APPROXIMATELY 18,000 BASES USED IN KEYFIT AND KEYFIT 30 REAR-FACING CHILD RESTRAINT SYSTEMS AND IN CORTINA TRAVEL SYSTEMS, AND STAND-ALONE BASES FOR THESE SYSTEMS PURCHASED SEPARATELY, THAT WERE MANUFACTURED BETWEEN FEBRUARY 26 AND MARCH 17, 2008. SOME OF THESE BASES HAVE A DEFECT THAT CAN PREVENT THE BASE FROM BEING TIGHTLY SECURED TO A VEHICLE WHEN THE LOWER LATCH ATTACHMENTS ARE USED AS A METHOD OF INSTALLATION. SPECIFICALLY, WHEN A DEFECTIVE BASE IS INSTALLED WITH THE LOWER LATCH ATTACHMENT STRAPS, THE WEBBING USED TO TIGHTEN THE BASE TO THE VEHICLE SEAT CAN SLIP THROUGH THE ADJUSTMENT LOCK.

Tristar Food Wholesale Co Inc. Issues a Nationwide recall of Blue Cat Flavor Drink Because of Possible Health Risk. The recall include all of their 100 ml plastic bottle packages of Blue Cat Flavor Drink (Lanmao) because it may be contaminated with Melamine.

Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100% Whole Wheat. People who have an allergy to these nuts run the risk of life threatening or serious allergic reactions if they consume the product.

GRACO IS RECALLING 121,042 CARGO BOOSTER SEATS (CHILD RESTRAINT SYSTEMS) MANUFACTURED BETWEEN JANUARY 9, 2007 AND MARCH 3, 2008. THESE SEATS WERE LABELED WITH AN INCORRECT TELEPHONE NUMBER FOR THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION (NHTSA) WHICH FAILS TO CONFORM TO THE LABELING REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 213, CHILD RESTRAINT SYSTEMS.

COMBI IS RECALLING 67,167 CENTRE, CENTRE ARB, AND SHUTTLE INFANT CHILD RESTRAINT SYSTEMS, MODEL NOS. 8065, 8074, 8086, 8087, AND 8520, AND ASSOCIATED TRAVEL SYSTEMS, MODEL NOS. 4400, 4515, AND 4520, THAT CONTAIN CENTRE AND SHUTTLE CAR SEAT MODELS. THIS RECALL INCLUDES THE ENTIRE PRODUCTION OF THESE MODELS FROM OCTOBER 2005 THROUGH DECEMBER 2007. IN THE EVENT OF A FRONTAL CRASH, THE CAR SEAT COULD POTENTIALLY BECOME SEPARATED FROM ITS BASE.

TECH INTERNATIONAL HAS RECALLED CERTAIN REPLACEMENT SNAP-IN TIRE VALVE STEMS, MODEL NOS. TR413, TR413CH, TR414, TR415, TR418, AND TR423, MANUFACTURED BETWEEN JULY AND NOVEMBER 2006. THE RUBBER PORTION OF THE VALVE STEM MAY CRACK AND PERMIT THE GRADUAL LOSS OF TIRE PRESSURE. CONTINUING TO DRIVE ON UNDER-INFLATED TIRES COULD DAMAGE THE TIRE, POSSIBLY RESULTING IN A VEHICLE CRASH.

Portland Shellfish Co. Inc, Recalls Claw Island Brand Lobster Claw and Knuckle Meat Because of Possible Health Risk. Lot 25508, packaged in 2 lb bags has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The retaining washers on the legs can loosen, causing the chair to become unstable. This poses a fall hazard to consumers. This recall involves the Colonial model, folding wooden chairs for use with game tables. They were sold in sets of two. The chairs have a black seat cushion and either a cherry or chestnut finish.

PREVOST IS RECALLING 189 MY 2008-2009 XLII-45, XLII-45E, X3-45 MOTOR HOMES AND H3-41 AND H3-45 MOTOR COACHES. DUE TO IMPROPER INSTALLATION OF THE ESCAPE HATCH RETAINING BOLTS, THESE BOLTS CAN BREAK.

ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets, (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an ''ETHEX'' label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with ''ETHEX" and ''311'' on one side.

EVENFLO IS RECALLING 1,038 DISCOVERY INFANT CHILD RESTRAINTS, MODELS 3021769Z AND 3021854Z, MANUFACTURED ON FEBRUARY 4, 2008. DUE TO A MANUFACTURING VARIABILITY, SOME UNITS MAY HAVE BEEN PRODUCED WITHOUT COMPLETE ASSEMBLY OF THE RELEASE HANDLE LOCATED ON THE BACK OF THE SEAT.

BFNT HAS RECALLED 2,101 DUELER H/T 684 II TIRES, SIZE P235/60R17, MANUFACTURED BETWEEN SEPTEMBER 16 AND OCTOBER 27, 2007. ONE SIDEWALL HAS A BLANK PLUG WHERE THE PARTIAL TIRE IDENTIFICATION NUMBER (TIN) SHOULD BE FOUND WHICH FAILS TO COMPLY WITH FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 139, "NEW PNEUMATIC RADIAL TIRES FOR LIGHT VEHICLES." Consequence:

GOODYEAR HAS RECALLED 5,300 DUNLOP WINTER SPORT 3D TIRES, SIZE 225/50R17 (DOT CODE DM40 2TTR), AND DUNLOP WINTER SPORT M3 TIRES, SIZE 275/35R18 (DOT CODE DMBL 2J8R), MANUFACTURED FROM SEPTEMBER 4, 2005, THROUGH MAY 17, 2008. THESE TIRES FAIL TO CONFORM TO THE TIRE STRENGTH REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 109, NEW PNEUMATIC TIRES.

POLARIS IS RECALLING 2,444 MY 2008 VICTORY VISION MOTORCYCLES. THE TERMINAL NUTS THAT SECURE THE MAIN POWER SUPPLY WIRES COULD BE LOOSE AT THE CIRCUIT BREAKER, WHICH CAN CAUSE AN UNEXPECTED LOSS OF ELECTRICAL POWER TO THE MOTORCYCLE AND THE CURRENT FUEL IGNITION MAP PRE-PROGRAMMED INTO THE ELECTRONIC CONTROL MODULE (ECM) CAN CAUSE ENGINE STALLING.

KAWASAKI IS RECALLING 5,804 MY 2008 KL650E8F AND KL650E8FL (CALIFORNIA) MOTORCYCLES. THE TURN SIGNAL STALK(S) CAN BREAK, RESULTING IN THE SIGNAL ASSEMBLY HANGING BY THE WIRE HARNESS. THIS COULD CREATE A POSSIBILITY OF A CRASH RESULTING IN INJURY OR DEATH.

Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks. The 3.88oz (110gm) packages of Fresh and Crispy Jacobina Biscuits are being recalled because it may be contaminated with Melamine.

Astro Meats & Seafood, Inc., a Miami, Fl., establishment, is recalling approximately 4,200 pounds of frozen beef trim that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service announced today. 60-pound bulk boxes of BM-95 BONELESS BEEF. Each shipping container bears the establishment number Nicaragua 4 inside the Nicaraguan mark of inspection. The shipping label bears the item number 00003, and pack date of 8-19-08.The frozen beef trim products were produced on Aug. 19, 2008, and were exported to the United States and then sent to distributors and establishments in Indiana and Wisconsin. These products were sent to establishments for further processing and will likely not bear the establishment number Nicaragua 4 on products available for direct consumer purchase.

Colorado Foods Products, a Greenwood Village, Co., establishment, is recalling approximately 2,340 pounds of frozen beef trim that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service. 60-pound bulk boxes of BM-95 BONELESS BEEF. Each shipping container bears the establishment number Nicaragua 4 inside the Nicaraguan mark of inspection. The shipping label bears the item number 00003, and pack date of 8-19-08. The frozen beef trim products were produced on Aug. 19, 2008, and were exported to the United States and then sent to distributors and establishments in California. These products were sent to establishments for further processing and will likely not bear the establishment number “Nicaragua 4” on products available for direct consumer purchase.

ADVANCED POWER SYSTEMS INTERNATIONAL, INC., (APS) IS RECALLING 2,000 AFTERMARKET FITCH FUEL CATALYST AUTOMOTIVE KITS WHICH COULD HAVE BEEN MANUFACTURED WITH A GATES BARRICADE 5/16" OR 3/8" FUEL HOSE, SOLD FOR USE ON VARIOUS PASSENGER CARS AND LIGHT TRUCKS. SUCH HOSES COULD RUPTURE, LEAKING FUEL IN THE ENGINE COMPARTMENT. THE PART NUMBERS OF THE KITS POSSIBLY CONTAINING THE AFFECTED HOSES ARE AS FOLLOWS: F3424, F3436, F3624, F3624-T, F36288, F3636, F3824, F3836, F38G24, F4424B, F4436B, F4624B, F4624TB, F4636, F46G24B, F4824B, F48G24B, F5624B, F56G24B, F5836B, F58G24B, F75424B, F75836B, F75624B, F75624BP, F75636BP, F756G24B, F75824BP, F75836BP, F758186BD, F758202BD, F75836BD, F75824BC, F7582618BC, F758G24B, F756242BC, F100624BP, F100824BP, F1008186BD, F10082618BC, F100824BC. A FUEL LEAK IN THE ENGINE COMPARTMENT COULD POSSIBLY RESULT IN A FIRE.

MITSUBISHI IS RECALLING 45,988 MY 2005-2007 ENDEAVOR, GALANT, ECLIPSE COUPE, AND MY 2007 ECLIPSE SPYDER VEHICLES. THE BRACKET THAT IS THE ATTACHMENT POINT FOR THE LEFT REAR FUEL TANK MOUNTING STRAP MAY HAVE BEEN IMPROPERLY FORMED DURING A METAL STAMPING PROCESS. THE PROCESS MAY HAVE CAUSED THE METAL TO HAVE A SPLIT IN THE AREA WHERE THE BOLT THAT HOLDS ONE OF THE TWO FUEL TANK STRAPS TO THE UNDERSIDE OF THE VEHICLE IS LOCATED. IN THE EVENT THE FUEL TANK IS FULL AND THE VEHICLE IS SUBJECT TO A SEVERE COLLISION, THE BRACKET MAY BREAK AND ALLOW THE FUEL TANK TO DROP DOWN, POSSIBLY CAUSING A FUEL LEAK.

KAWASAKI IS RECALLING 604 MY 2008 VULCAN VN900C8F, VN900D8F, AND MY 2009 VN900B9F, AND VN900B9FL MOTORCYCLES. FUEL CAN LEAK FROM BETWEEN THE TANK FILLER NECK AND THE FUEL CAP GASKET. FUEL LEAKAGE IN THE PRESENCE OF AN IGNITION SOURCE CAN RESULT IN A FIRE.

Wal-Mart Recalls General Electric Toasters Due to Fire and Shock Hazards. Hazard: An electrical short circuit can occur between the heating element and the bread cage, posing a fire and electrical shock hazard to consumers. Incidents/Injuries: Wal-Mart has received 140 reports of fires or sparks coming from the toasters or the toasters tripping the circuit breaker in consumers’ homes. No injuries have been reported. Description: The recalled toasters have a chrome steel body, a black plastic base and controls with either two or four openings in the top. The GE logo is located on the front of the toasters just above the controls. Model numbers 169115 and 169116 are included in this recall. The model number is printed on the bottom of the toasters. 4-Slice 2-Slice 169115 16911

Rack Room Shoes Recalls Girls’ Sandals Due to Choking Hazard. The recalled girls' sandals are leather with attached leather flowers and were sold under the Kids Feet name. The sandals are white or white with pink soles. The sandals were sold in girls' sizes 5 through 12.

Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry & David Moose Munch Confection, Milk Chocolate Gingerbread.Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry & David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product.

Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System. Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.

Thoratec Corporation initiated a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months. Patients who are currently being supported by a HeartMate II LVAS should contact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead. Thoratec voluntarily issuied an Urgent Medical Device Correction notice after confirming 27 reports where wear and fatigue to the percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants. All patients who have undergone a replacement of the HeartMate II pump survived the operation and were alive at least 30 days postoperatively. In five cases, pump replacement was not feasible and the patients expired. The affected systems were distributed to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalogue number located on the label of the package.

Shivvers Manufacturing Recalls Lawn Mower Jacks Due to Collapse Hazard. Hazard: The jack lifts can have threads stripping or the nuts breaking, resulting in the shaft slipping and the mower falling from its stand-up position. This could cause serious personal injury to the consumer or property damage. Incidents/Injuries: Shivvers has received five reports of jack lift failures and 37 warranty claims for replacement parts. Description: The recalled jacks are used for lifting the lawn mower during service or maintenance. Two versions of this jack model have been manufactured. Version number one was made with a nylon nut and version number two was made with a sintered bronze nut. These recalled jacks were sold separately and on Charger, JAZee and Boss riding lawn mowers.

Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Crème filled Cookies. they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap and the recall includes the following products: Koala March King Size Chocolate 1.8 oz 50 grams UPC 0 81900 00001 7 Koala March King Size Strawberry 1.8 oz/50 grams UPC 0 81900 00007 9 Koala March King Size White Chocolate 1.8 oz/50 grams UPC 0 81900 00011 6 Koala March Family Pack Chocolate 9.5 oz/270 grams UPC 0 81900 08001 9 Koala March Family Pack Strawberry 9.5 oz/270 grams UPC 0 81900 08002 6 Koala March Family Pack White Chocolate 9.5 oz/270 grams UPC 0 81900 08011 8 Koala March Family Pack Chestnut 9.5 oz/270 grams UPC 0 81900 08010 1 Koala March Family Hawaii Chocolate 9.5 oz/270 grams UPC 0 81900 08003 3 Koala March Family Hawaii Pineapple 9.5 oz/270 grams UPC 0 81900 08004 0

Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips. This recall was determined necessary after it was identified by 3 consumers that packages of Kroger Value Semi Sweet Chocolate Chips may also contain chocolate chips with undeclared milk protein. The package ingredient label does not identify that the product may contain milk protein.

BABY TREND IS RECALLING 5,787 LATCH-LOC CAR SEATS, MODELS MAGNUM 6439, GALAXY 6481, SILVERADO 6448, AND 6400S STAND ALONE BASES, MANUFACTURED BETWEEN MAY 14, 2007 AND APRIL 1, 2008. INCORRECT STEEL WAS USED ON THE LATCH CONNECTOR LOCKING PAWL.

John Jaques & Son Recalls Lawn Dart Games Due to Risk of Puncture. Hazard: The darts in the games pose a puncture hazard to young children. Lawn darts were banned in December 1988 to protect children from skull, face and eye puncture wounds. Incidents/Injuries: None reported. Description: The recalled lawn dart game includes four projectiles, each consisting of a 14 3/4” bamboo shaft, four fins, and a wooden tip.

DEL-NAT HAS RECALLED 968 LOAD RANGE E TIRES, SIZE LT265/75R16, PRODUCED BETWEEN DECEMBER 2 AND DECEMBER 30, 2007. THESE TIRES FAIL TO CONFORM TO THE REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 139, NEW PNEUMATIC RADIAL TIRES FOR LIGHT VEHICLES. AFTER TESTING, A BULGE CAN OCCUR IN THE LOWER SIDEWALL ON THE WHITE SIDEWALL SIDE WHICH INDICATES THE EXISTENCE OF A SEPARATION BETWEEN TWO LOWER SIDEWALL COMPONENTS. THIS CONDITION COULD RESULT IN A VEHICLE CRASH.

PRO COMP IS RECALLING 1,206 LOAD RANGE E TIRES, SIZE LT265/75R16, PRODUCED BETWEEN DECEMBER 2, 2007 AND JANUARY 12, 2008. THESE TIRES FAIL TO CONFORM TO THE REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 139, NEW PNEUMATIC RADIAL TIRES FOR LIGHT VEHICLES. AFTER TESTING, A BULGE CAN OCCUR IN THE LOWER SIDEWALL ON THE WHITE SIDEWALL SIDE WHICH INDICATES THE EXISTENCE OF A SEPARATION BETWEEN TWO LOWER SIDEWALL COMPONENTS.

BLUE BIRD IS RECALLING 803 MY 2006 THROUGH 2009 MICRO BIRD SCHOOL BUSES MANUFACTURED FROM JULY 27, 2005, THROUGH AUGUST 20, 2008, EQUIPPED WITH OPTIONAL WHEELCHAIR LIFTS. THE WHEELCHAIR LIFT ENABLE SWITCH, IF SET TO THE "OFF" POSITION WHILE THE LIFT IS DEPLOYED CAN RENDER THE WHEELCHAIR INTERLOCKS INOPERATIVE.

BLUE BIRD IS RECALLING 803 MY 2006 THROUGH 2009 MICRO BIRD SCHOOL BUSES MANUFACTURED FROM JULY 27, 2005, THROUGH AUGUST 20, 2008, EQUIPPED WITH OPTIONAL WHEELCHAIR LIFTS. THE WHEELCHAIR LIFT ENABLE SWITCH, IF SET TO THE "OFF" POSITION WHILE THE LIFT IS DEPLOYED CAN RENDER THE WHEELCHAIR INTERLOCKS INOPERATIVE.

Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes. This product is being recalled because it contains milk, soy, and wheat that was distributed in packaging that does not reveal the presence of these ingredients. People who have an allergy or severe sensitivity to milk, soy, or wheat run the risk of a serious or life-threatening allergic reaction if they consume these products.

BRP U.S. Inc. Recalls Youth All Terrain Vehicles Due to Collision Hazard. Hazard: If the rider is ejected and the cord strap is pulled, the shutoff switch can fail to disable the engine. The ATV can operate uncontrolled, until the engine returns to idle, and cause a collision with bystanders, vehicles or other objects. This poses a serious risk of injury. Incidents/Injuries: None. Description: The recall involves Model Year 2008-2009 Can-Am® DS 90 X ATVs. The model name can be located on the side panels. The ATV is black with yellow and orange trim.

Mr. Brown instant coffee and milk tea products were being recalled by the Taiwanese company, King Car Food Industrial Co. Ltd., due to possible contamination with melamine. King Car Food Industrial Co. used a non-dairy creamer manufactured by Shandong Duqing Inc., China, which was found to be contaminated with melamine. The recalled products are: Mr. Brown Mandheling Blend Instant Coffee (3-in-1) Mr. Brown Arabica Instant Coffee (3-in-1) Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1) Mr. Brown Caramel Macchiato Instant Coffee (3-in-1) Mr. Brown French Vanilla Instant Coffee (3-in-1) Mr. Brown Mandhling Blend instant Coffee (2-in-1) Mr. Brown Milk Tea (3-in-1)

The FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.

Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates. Consumers allergic to hazelnuts run the risk of a serious allergic reaction if they consume this piece of candy.

General Mills Issues Voluntary Class One Recall Involving One Day's Production of Progresso Hearty Tomato Soup because of a product labeling issue. Product produced on this date may have been mislabeled, and may contain allergens not listed on the ingredient label, specifically egg, milk, and soy.

The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA also required the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS. Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy to control their psoriasis. The FDA's Office of Surveillance and Epidemiology, charged by the Agency with monitoring drugs once approved for the marketplace, has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva. The now-required Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections. Additionally, Raptiva's label will be updated to include data from juvenile animal studies in mice (age equivalent to a 1-14 year old human). These data indicate a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children under 18 years of age. "As part of FDA's monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva. These reports led to our decision to highlight these risks in the drugs labeling," said Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research. "Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks." Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, however by suppressing the body's natural defense system, it can also increase the risk of serious infections and malignancies in patients. Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Vaccinations should not be administered to patients taking Raptiva because immunity to the vaccination virus may not be conferred. Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face. If any of these signs appear, Raptiva patients should seek immediate medical attention. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva. Because reports of these adverse events were received voluntarily from populations of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug's use. One report of PML in a Raptiva-treated patient came from an ongoing post-marketing epidemiological study of patients with psoriasis.

This recall involves batteries with serial numbers listed below sold with the TF-DVD 1020 portable DVD/CD/MP3 players. The battery’s serial number can be found on a white sticker affixed to it. The product looks like a small laptop computer and has a 10'' swivel TV screen. COBY is written on the front cover and under the screen. TF-DVD 1020 can be found on the bottom of the unit.

BMW IS RECALLING 560 MY 2009 JCW (JOHN COOPER WORKS) AND JCW CLUBMAN VEHICLES EQUIPPED WITH 16 INCH DIAMETER FRONT BRAKE DISCS RATHER THAN 17 INCH DISCS. UNDER CONDITIONS OF INTENSE BRAKE USAGE, BRAKING PERFORMANCE WOULD BE REDUCED.

Ski-Doo Snowmobiles Recalled by BRP US Inc. Due to Drive Axle Failure. Riders Can Be Thrown From Snowmobile. Hazard: Cracks can develop in the welded joints of the drive axle assembly of the snowmobile and can result in complete breakage. If this happens the track of the vehicle can unexpectedly lock, causing riders to be ejected off the vehicle or lose control and collide with bystanders, a fixed object or other vehicles. This poses a risk of serious injury or death. Incidents/Injuries: BRP has received 20 reports of locked tracks, including one report of a broken femur and reports of minor injuries such as bruises. Description: This recall involves Ski-Doo® Model Year 2008 and 2009 snowmobiles. Models included in the recall are listed below. Model numbers are printed on the side panels of the snowmobiles. Ski-Doo® Model Year 2008 MXZ X 800R PowerTEK MXZ X 600HO SDI MXZ Adrenaline 800R PowerTEK MXZ Adrenaline 600HO SDI MXZ TNT 500SS MXZ Trails 500SS GSX Limited Touring 600HO SDI GSX Limited 800R PowerTEK GSX Limited 600HO SDI GSX Sport 500SS MXZ Renegade X 800R PowerTEK MXZ Renegade X 600HO SDI MXZ Renegade 800R PowerTEK MXZ Renegade 600HO SDI Summit X 800R Power TEK Summit Everest 800R PowerTEK MXZ X 600RS

Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Blend Dry Cat Food Sold at Wal-Mart Locations in Fifteen States Due to Potential Salmonella Contamination.

AMERICAN PACIFIC INDUSTRIES, INC., (API) HAS RECALLED 4,738 SPECTOR ADVANTA SUV ROWL RADIAL LIGHT TRUCK TIRES, SIZE P255/70R16 109S, MANUFACTURED BETWEEN FEBRUARY 3 AND MARCH 1, 2008. THESE TIRES MAY HAVE A THIN AREA OF RUBBER ON A PORTION OF THE TIRE BEAD AREA.

GM IS RECALLING 42,408 MY 2008-2009 SATURN VUE VEHICLES. SOME OF THESE VEHICLES HAVE A CONDITION IN WHICH THE NUT SECURING THE POWER STEERING LINE TO THE POWER STEERING PUMP MAY LOOSEN. IF THIS WERE TO OCCUR, THERE MAY BE A POWER STEERING FLUID LEAK.

MERCEDES-BENZ IS RECALLING 102,954 MY 1998-2003 M-CLASS VEHICLES. THE HOSE CLAMP USED TO SECURE THE POWER STEERING FLUID COOLING HOSE TO THE POWER STEERING FLUID COOLER MAY NOT PROVIDE SUFFICIENT CLAMPING FORCE FOR THIS CONNECTION. THE LOSS OF POWER STEERING FLUID MAY RESULT IN DIMINISHED POWER STEERING OVER TIME AND ULTIMATELY CAN DAMAGE THE POWER STEERING PUMP. THIS COULD RESULT IN A LOSS OF CONTROL AND A CRASH WITHOUT WARNING.

PIRELLI HAS RECALLED 8,273 TIRES, SIZE LT 235/80 R 17 LOAD RANGE E, PRODUCED FROM JULY 11, 2005 TO OCTOBER 30, 2007. TREAD CHUNKING, TREAD CHUNKOUT, PARTIAL TREAD SEPARATION AND/OR BELT EDGE SEPARATION CAN OCCUR.

BFNT IS RECALLING 4,202 BRIDGESTONE BIAS MOTORCYCLE AND MOTORCYCLE SCOOTER TIRES THAT FAIL TO CONFORM TO THE LABELING REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 119, NEW PNEUMATIC TIRES FOR MOTOR VEHICLES WITH A GVWR OF MORE THAN 4,536 KILOGRAMS (10,000 POUNDS) AND MOTORCYCLES.

Toy Police Cars Recalled by TCB Imports Due to Violation of Lead Paint Standard. The red paint on the toy cars contains excess levels of lead, violating the federal lead paint standard.

FDA notified healthcare professionals of a Class I Recall of theVibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Electromagnetic Field Generator. This product was manufactured and distributed from November 16, 2002 through March 19, 2008. This device was not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices. The manufacturer submitted no evidence to FDA to support any of their claims that the product could treat or cure such diseases as cancer, depression, infection and pain.

Viessmann U.S. Recalls Boilers Due to Fire Hazard.Hazard: The boiler can leak gas, posing a fire hazard to consumers. Incidents/Injuries: None reported. Description: The recall involves the Vitodens 200 boiler. The gas-fired boilers are white, wall-mounted and have “Viessmann” and “Vitodens 200” printed on the exterior in silver letters. The model and serial numbers included in the recall are listed below. The model number is located on the silver rating plate on the side of the boiler. Contact your certified HVAC contractor to open the boiler and locate the serial number on a white label on the side of the boiler, or under the bottom support panel. Vitodens 100 boilers are not included in this recall. Model Number Serial Number Additional Information WB2 6-24C 7167063xxxxxxxxx or 7170317xxxxxxxxx If the serial number’s 8th digit (listed in red) is a 2, 3, 4, 5 or 6, the boiler is included in the recall. WB2 6-24 7167064xxxxxxxxx or 7170318xxxxxxxxx WB2 8-32 7167065xxxxxxxxx or 7170319xxxxxxxxx WB2 11-44 7167066xxxxxxxxx or 7188578xxxxxxxxx WB2 15-60 7167067xxxxxxxxx or 7188577xxxxxxxxx

HUA XIA Food Trade USA, Inc. Recalls YILI Brand Sour Milk Drink and YILI Brand Pure Milk Drink, Because of Possible Health Risk in that it may be contaminated with melamine.

CPSC and Chance Rides Manufacturing Announce Recall to Inspect and Repair YO-YO Amusement Rides. CPSC has received reports of two incidents involving the YO-YO ride resulting in injuries to children and adults, including scraped knees and back strains. On May 16, 2008, 23 riders of a YO-YO ride in Angels Camp, Calif. fell to the ground when the sweep arms suspending the circular swinging chairs they were riding in broke free from the ride’s center cylinder rod. The inspection program will focus on preventing future failures.

GM HAS RECALLED 296,422 MY 2006-2008 CHEVROLET HHR VEHICLES FOR FAILING TO COMPLY WITH THE REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 201, OCCUPANT PROTECTION IN INTERIOR IMPACT. THE DOOR ON THE STORAGE BIN IN THE TOP CENTER OF THE INSTRUMENT PANEL FAILED TO REMAIN CLOSED AS REQUIRED.

Razor Dirt Quad Electric Powered Ride-On Vehicles Hazard: The control module for the throttle can fail and cause the electric ride-on vehicle to unexpectedly surge forward, posing a risk of injury to the user or a bystander. Incidents/Injuries: Razor has received 60 reports of the vehicles unexpectedly surging forward, including two reports of injuries. Description: This recall involves Razor® Dirt Quad electrically powered ride-on vehicles. Product ID numbers included in the recall begin with 103110-01 or 103110-02. The product ID numbers are located on the bar code affixed to the right step of the vehicle, on the charger and on the retail packaging. Product ID numbers beginning with 103110-03 or later are not included in this recall.

Worldwise Inc. Recalled Retractable Dog Leashes, Metal Clasp Can Break and Cause Facial and Body Injuries to Dog Owners: The metal clasp connecting the leash to a dog's collar can bend or break while in use, causing the leash to recoil back unexpectedly. This poses a serious risk of injury to consumers. This recall involved the SlyDog Retractable Dog Leash with a metal clasp. The leash has a handle composed of a blue plastic case with a black plastic grip. The leash is made of a black woven strap and measures approximately one-half inch wide. The end of the leash has a metal clasp which connects to the dog's collar. The SlyDog retractable leashes with a plastic clasp are not included in this recall.

Pottery Barn Recalls Wooden Hammock Stands Due to Fall and Laceration Hazard. Hazard: When used outdoors, the wood in the hammock stand can deteriorate over time and break, posing a risk of falls and lacerations to consumers. Incidents/Injuries: Pottery Barn has received 12 reports of injuries requiring medical attention, including lacerations, neck and back pain, bruising, and one incident involving fractured ribs and about 50 reports of the hammock stand breaking. Description: The wooden hammock stands measure about 154 ½ inches long by 53 ½ inches in height by 53 inches in width. There are two black metal brackets on the base and on the arms of the hammock stand. All Pottery Barn two pole wooden hammock stands sold from 2003 through 2008 are included in this recall.

The recalled rug measures 30 x 54 The rugs do not meet the federal flammability standard for small rugs and do not have the required flammability warning label and has a black-and-white zebra skin design. The rug was sold under J.C. Penney item number MF728-1050, which is located on the product's packaging.

Food Evolution., a Schiller Park, IL, firm, has recalled approximately 16 pounds of ready-to-eat turkey product that may be contaminated with Listeria monocytogenes.The following product is subject to recall: 13-ounce individually wrapped packages of Turkey Burrito Wrap. Each package bears the establishment number P-34309 inside the USDA mark of inspection and a sell-by date of September 27, 2008.

GM HAS RECALLED 296,422 MY 2006-2008 CHEVROLET HHR VEHICLES FOR FAILING TO COMPLY WITH THE REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 201, OCCUPANT PROTECTION IN INTERIOR IMPACT. THE DOOR ON THE STORAGE BIN IN THE TOP CENTER OF THE INSTRUMENT PANEL FAILED TO REMAIN CLOSED AS REQUIRED. THIS STANDARD SPECIFIES PERFORMANCE REQUIREMENTS TO PROVIDE HEAD IMPACT PROTECTION FOR OCCUPANTS.

Optave Inc. Recalled Action Baby Carriers Due to Fall Hazard: The baby carrier's chest strap can detach from the shoulder straps, posing a fall hazard to the baby. The recalled carriers were sold under the Action Baby Carrier brand name. The carriers are sold in various colors and patterns: blue, brown, green, so square, the larrisa and spring breeze.

Ucyclyd Pharma, Inc. informed healthcare professionals of the detection of particulate matter in the Ammonul Injection product. This particulate matter may impact the safe use of Ammonul. To ensure optimal patient care, healthcare providers are being instructed to use a MilIex Durapore GV 33 mm Sterile Syringe Filter (0.22 µm ) during the admixture process when injecting Ammonul into the 10% Dextrose IV bag. Since this particulate matter may not be readily seen on visual inspection, a filter must be employed in all cases regardless of whether particulate matter is seen in the vial. Testing has confirmed the removal of this specific particulate when using this filter to admix Ammonul.

Sony recalled notebook computers due to burn hazard. Irregularly positioned wires near the computer's hinge and/or a dislodged screw inside the hinge can cause a short circuit and overheating. This poses a burn hazard to consumers. The recalled notebook computer models are the VAIO VGN-TZ100 series, VGN-TZ200 series, VGN-TZ300 series and VGN-TZ2000 series. The computers' screen size is about 11.1 measured diagonally. Not all units are affected.

Bicycles with Deda Forza Handlebar Stems Recalled by Deda Elementi Due to Crash Hazard: The top of the bicycle handlebar stem can crack and cause the rider to lose control, posing a crash hazard. This recall involved bicycles with Deda Forza black carbon fiber handlebar stems in gloss finish. Deda Forza is printed on the handlebar stem. Deda Forza black carbon fiber handlebar stems in matte finish are not included in this recall.

POLARIS IS RECALLING 2,444 MY 2008 VICTORY VISION MOTORCYCLES. THE TERMINAL NUTS THAT SECURE THE MAIN POWER SUPPLY WIRES COULD BE LOOSE AT THE CIRCUIT BREAKER, WHICH CAN CAUSE AN UNEXPECTED LOSS OF ELECTRICAL POWER TO THE MOTORCYCLE AND THE CURRENT FUEL IGNITION MAP PRE-PROGRAMMED INTO THE ELECTRONIC CONTROL MODULE (ECM) CAN CAUSE ENGINE STALLING. EITHER CONDITION COULD CAUSE THE ENGINE TO STALL, INCREASING THE RISK OF A LOSS OF CONTROL AND A CRASH.

The FDA announced that it had been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product. Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.

Fairy Dust Pendants and Candle Charms Recalled Due to Risk of Lead Exposure: The recalled metal pendants and charms contain high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects. The recalled pewter pendants were sold in a collection of 12 pendants. The pendants were sold separately and on candles of various colors and scents.

Nestlé Prepared Foods Company, a Mt. Sterling, Ky., establishment, is recalling approximately 215,660 pounds of frozen stuffed pepperoni pizza sandwich products that may contain foreign materials, the U.S. Department of Agriculture's Food Safety and Inspection Service announced today. The following products were recalled: 54-ounce, 12-pack cartons of HOT POCKETS PEPPERONI PIZZA brand stuffed sandwiches. Printed on the side of each carton is 8157544614D, EST 7721A, and BEST BEFORE JAN2010. Each carton bears the USDA mark of inspection.

This recall involved the DE and PSC II Gas Fired Cast Iron Boilers with the Endura Plastics Model ES2035 pressure switch used for home heating and domestic hot water heating. The boilers were available in either natural or LP gas. The boiler rating label is located on the top jacket panel on Series PSCII models and the left side jacket panel on the Series DE models. The label includes the model and serial number. The following model names and serial numbers are included in the recall: Model Name Serial Number DE-03, DE-04, DE-05 and DE-06 5040768 to 5052860 PSCII-03, PSCII-04, PSCII-05, and PSCII-06 5040777 to 5052166.

Empress Arts Ltd., of Monterey Park, Calif. has recalled hooded sweaters which have drawstrings through the hood. Children can get entangled in the drawstrings that can catch on playground equipment, fences or tree branches. In February 1996, CPSC issued guidelines to help prevent children from strangling or getting entangled on the neck and waist drawstring in upper garments, such as jackets and sweatshirts. From 1985 through June 2008, CPSC received reports of 27 deaths and 70 non-fatal incidents involving the entanglement of children's clothing drawstrings. : The cotton knit sweaters are cream colored with a blue stripe at the wrists and waist, a blue ball on the hood, and blue buttons. There is a drawstring through the hood with pom-poms at the ends. The sweaters were sold in children's size 2T under the brand name Empress Arts. Empress Baby is sewn into the sweaters tag. Products were sold at: Specialty children's stores nationwide from August 2006 through April 2008 for between $28 and $45.

The FDA issued a Health Information Advisory to consumers and healthcare professionals regarding milk-based infant formula manufactured in China. The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can cause kidney diseases. Currently, no Chinese manufacturers of infant formula have fulfilled the requirements to sell this product in the United States. FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Caregivers should not feed infant formula manufactured in China to infants and should replace any product from China with an appropriate infant formula manufactured in the United States.

LifePak CR Plus Automated External Defibrillator was manufactured from May 20, 2004 through August 11, 2007 and distributed from May 20, 2004 through December 4, 2007. These devices are used by emergency or medical personnel, or by others who have taken the appropriate training to use this AED. The devices are intended to treat adults in cardiopulmonary arrest (heart attack). They analyze an unconscious patient’s heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm. The AED instructs the responder, by voice prompts, to press the shock button. However, the shock button is covered and is not visible. Therefore, the responder is not able to provide therapy (shock).

Cordless Screwdrivers Recalled by Menards Due to Fire and Burn Hazards: The battery can overheat and ignite during charging, posing a fire and burn hazard to consumers. There is no protective device on the lithium battery to prevent overheating. The recalled cordless screwdrivers are green and gray in color. MASTERFORCE is printed on the top of the tool. LITHIUM-ION TECHNOLOGY and 241-0717 are printed on the handle.

Palama Holdings, LLC, a Kapolei, Hawaii, establishment, has recalled approximately 4,535 pounds of fully cooked pork products because they may be contaminated with Listeria monocytogenes.

HELMET CITY IS RECALLING 2,266 MOTORCYCLE HELMETS, MODEL #50, SIZES XS THROUGH XXL. THESE HELMETS FAIL TO CONFORM TO THE IMPACT REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 218, MOTORCYCLE HELMETS. IN THE EVENT OF A CRASH, THE WEARER OF ONE OF THESE HELMETS MAY NOT BE ADEQUATELY PROTECTED, POSSIBLY RESULTING IN PERSONAL INJURY.

YAMAHA HAS RECALLED 4,800 MY 2007 XF50 AND XC50 MOTORCYCLES. A CRACK MAY DEVELOP ON THE CONNECTING ROD. IF THE ENGINE CONTINUES TO BE RUN, THE CRACK WILL DEVELOP FURTHER AND THE CONNECTING ROD MAY BREAK. IF THE CONNECTING ROD BREAKS, THE ENGINE WILL STOP AND CANNOT BE RESTARTED INCREASING THE RISK OF A CRASH

CHRYSLER HAS RECALLED 494 MY 2008 JEEP LIBERTY VEHICLES. THE WINDSHIELD AND/OR FIXED REAR QUARTER GLASS MAY HAVE BEEN ASSEMBLED USING INCORRECT URETHANE ADHESIVE. THIS COULD AFFECT GLASS RETENTION. IF THE GLASS SEPARATES WHILE DRIVING, IT COULD STRIKE ANOTHER VEHICLE OR INJURE A PEDESTRIAN.

TRIUMPH HAS RECALLED 372 MY 2008 SPRINT ST MOTORCYCLES. THERE IS A POSSIBILITY THAT THE SINGLE BOLT THAT IS USED IN THE 3 POSITIONS ON THE REAR SUSPENSION DRAG LINK ASSEMBLY CAN BECOME BRITTLE AND FRACTURE. THE BOLTS INVOLVED ARE THE 1- DRAG LINK TO DROP LINK BOLT, 2- DRAG LINK TO FRAME BOLT, AND 3- DROP LINK TO REAR SUSPENSION UNIT BOLT.

POLARIS IS RECALLING 2,444 MY 2008 VICTORY VISION MOTORCYCLES. THE TERMINAL NUTS THAT SECURE THE MAIN POWER SUPPLY WIRES COULD BE LOOSE AT THE CIRCUIT BREAKER, WHICH CAN CAUSE AN UNEXPECTED LOSS OF ELECTRICAL POWER TO THE MOTORCYCLE AND THE CURRENT FUEL IGNITION MAP PRE-PROGRAMMED INTO THE ELECTRONIC CONTROL MODULE (ECM) CAN CAUSE ENGINE STALLING.

CHRYSLER HAS RECALLED 6,636 MY 2008-2009 DODGE CHALLENGER VEHICLES EQUIPPED WITH AUTOMATIC TRANSMISSIONS AND "KEYLESS GO" OPTION FOR FAILING TO CONFORM TO THE REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 114, THEFT PREVENTION. IF THE STOP/START BUTTON IS PRESSED AND HELD AND THE ENGINE TURNS OFF, THE ELECTRONIC KEY CODE IS REMOVED FROM THE VEHICLE. SINCE THIS CAN OCCUR IN A TRANSMISSION OR GEAR SELECTOR POSITION OTHER THAN PARK, AND THE TRANSMISSION OR GEAR SELECTOR DOES NOT BECOME LOCKED IN "PARK" AS A DIRECT RESULT OF KEY REMOVAL, IT WAS DETERMINED THAT A NONCOMPLIANCE MAY EXIST.

SOUTHEAST TOYOTA IS RECALLING 64 MY 2008-2009 SCION XB VEHICLES INSTALLED WITH THE SPORTS GRILL OPTION AND ALSO SEVERAL RADIATOR GRILLS SOLD AS PARTS. THESE VEHICLES FAIL TO COMPLY WITH THE REQUIREMENTS OF FEDERAL MOTOR VEHICLE SAFETY STANDARD NO. 113, HOOD LATCH SYSTEM. IT HAS BEEN DETERMINED THAT SHOULD THE PRIMARY HOOD LATCH BE RELEASED OR FAIL, THE PLASTIC UPPER RADIATOR GRILL GARNISH COULD RELEASE THE SECONDARY LATCH AND CAUSE THE HOOD TO OPEN.

NISSAN IS RECALLING 3,403 MY 2009 ALTIMA VEHICLES EQUIPPED WITH 16-INCH ALLOY WHEELS. SOME THESE WHEELS MAY NOT HAVE BEEN MANUFACTURED TO SPECIFICATION. THIS COULD CAUSE ONE OR MORE OF THE FIVE LUG NUTS ATTACHING THE WHEEL TO THE VEHICLE TO BECOME LOOSE.

Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease. Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). This drug is not indicated in the intra-articular treatment of hemarthroses. Additionally, post marketing experience identified radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity. Healthcare professionals should refer to the product's revised prescribing information for updated information regarding the appropriate use of Phosphocol P 32.

Nebraska Beef, Ltd., an Omaha, Neb., establishment, is clarifying information from and expanding its recalling of primal cuts, subprimal cuts and boxed beef to include such products bearing the company name Nebraska Beef Ltd that may be contaminated with E. coli O157:H7.

This recall involved the Protocol remote-controlled mini helicopter toys with model number starting with 1442. The helicopter is made of foam and plastic and measures about 7 inches long. Protocol is printed on the tail and on the side of the helicopter.1442-X can be found on the packaging. The remote-control component measures 5 1/2 inches by 4 3/4 inches. The rechargeable battery inside the helicopter can overheat. This can result in the helicopter’s body melting, as well as a risk of fire or burns to consumers.

Razor Scooters Hazard: The undersides of the foot platforms can have sharp edges, posing a laceration hazard to children. Incidents/Injuries: Razor has received 10 reports of Achilles tendon or ankle lacerations, including four consumers who required tendon surgery and three who needed stitches. Description: The PowerWing is a three-wheeled scooter, which was sold in either black or silver. The recall includes products with serial numbers beginning with: Y708 Y709 Y710 Y711 Y712 Y801 Y802 Y803 Y804 Y805 Y806 Y807 Y808

Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan. Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated.

OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN. Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range. New information from a pharmacokinetic study