2016 Product Recalls

6,940 recalls issued in 2016.

6,940
Total Recalls
138
USDA
330
CPSC
1,254
FDA Drug
USDA 138 CPSC 330 FDA Drug 1,254 FDA Device 1,186 NHTSA 1,021 FDA Food 3,011

Showing 6921–6940 of 6,940 recalls

USDA Class I

Neto's Sausage Co., Inc. Recalls Meat and Poultry Products Produced Without Benefit of Inspection

Produced Without Benefit of Inspection

FDA

Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator support, delivered invasively or noninvasively, to patients who

Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.

Covidien sent an Urgent Field Safety Notice on January 12, 2015, to all affected customers. Customers were requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Covidien is updating software that will modify ventilator alarms and status display messages during a GUI reset. The Puritan Bennett 980 Ventilator Operator Manual will be updated to delete,replace ventilator during a GUI transient reset, and to inform users to monitor the secondary status display until the primary display refreshes. Covidien will communicate with customers when the software and operator manual updates are available. Customers with questions were instructed to contact Technical Support Department at 800-255-6774, option 4, and then option 1. For questions regarding this recall call 303-876-8870.

FDA Class I

Helados La Tapatia Creamy Fruit Bars; Esquimal eskimo; Net Wt. 3 FL oz; UPC 6 34242 20012 8; INGREDIENTS: ICE CREAM MIX (CREAM, MILK, NONFAT MILK SOLIDS, STABILIZER (LOCUST BEAN GUM, GUAR GUM)), WATER, SUGAR, VANILLA FLAVOR (PROPYLENE GLYCOL, WATER AND CARAMEL COLOR), YUKON CHOCOLATE (COCONUT OIL, SUGAR, COCOA POWDER, WHEY POWDER (MILK) SOY LECITHIN ADDED AS AN EMULSIFIER AND VANILLA), STABILIZER (XANTHAN GUM, GUAR GUM, "STANDARDIZED WITH DEXTROSE), CORN OIL, PEANUTS AND YELLOW COLOR (WAT

Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.

FDA Class I

TATE'S BAKE SHOP CHOCOLATE CHIP COOKIES, NET WT. 7 OZ (198 G), UPC Code 810291001002, product is packed in plastic which is inserted into green paper wrapping, DISTRIBUTED BY: TATE'S BAKE SHOP 43 NORTH SEA RD. SOUTHAMPTON NY 11968 631-780-6511, WWW.TATEBAKESHOP.COM, MADE IN THE U.S.A.

Tate's Bake Shop has recalled Chocolate Chip Cookies and Ginger Zinger Cookies due to the presence of undeclared walnuts.

FDA Class I

Helados La Tapatia Creamy Fruit Bars; Cookies "n" Cream; Net Wt. 3 FL oz; UPC 6 34242 20010 4; INGREDIENTS FOR MILK BARS: ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80, CARRAGEENAN}, CHOCOLATE COOKIES (ENRICHED FLOUR (WHEAT FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE (VITAMIN B1 RIBOFLAVIN (VITAMIN 82), FOLIC AOD), SOYBEAN AND PALM OIL WITH TBHQ FOR FRESHNESS, COCOA PROCESSED WITH ALKALI, INVERT SUGAR CONTAIN

Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling..

FDA Class II

CPT05 5 Ounce Pizza Dough Ball, 112 - 5 Ounce Dough Balls, Net Weight 35.0 Pounds, UPC 1 081267 0012644 4..

The Dough Shop is recalling one lot of pizza dough because a piece of vinyl glove was found in the product.

FDA Class I

Helados La Tapatia Creamy Fruit Bars; Pecan Nuez; Net Wt. 3 FL oz; UPC 6 34242 20007 4; INGREDIENTS FOR MILK BARS: ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80 CARRAGEENAN), WATER, SUGAR, MAPLE BUTTER FLAVOR (PROPYLENE GLYCOL, WATER AND GLYCERIN), STABILIZER (XANTHAN GUM, GUAR GUM, STANDARDIZED WITH DEXTROSE), CARAMEL COLOR AND NATURAL FRESH PECANS. PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS CONTAIN

Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling..

FDA Class I

Helados La Tapatia Creamy Fruit Bars; Pina Colada; Net Wt. 3 FL oz; UPC 6 34242 20014 2; INGREDIENTS FOR MILK BARS: ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR,CORN SYRUP. MONO AND DIGLYCERIDES, CELLULOSE GUM,GUAR GUM,POLYSORBATE 80 CARRAGEENAN),WATER,SUGAR,FRESH COCONUT, FRESH PINEAPPLE. COCONUT FLAVOR (WATER,SUCROSE,VEGETABLE OIL (COCONUT), MODIFIED CORNSTARCH,ARTIFICIAL FLAVORINGS,BROMINATED VEGETABLE OIL 0.03% ANHYDROUS CITRIC ACID, SODIUM BENZOATE (PRESERVATIVE), PROPYLEN

Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.

NHTSA

Electric Entry Steps may be Unstable

Unstable entry and exit steps increase the risk of injury.

Foretravel will notify owners and dealers will install a retainer bracket to reinforce the operating mechanism, free of charge. The recall began on February 20, 2016. Owners may contact Foretravel customer service at 1-936-564-8367, or Lippert customer service at 1-574-537-8900.

NHTSA

Driveshaft may Disconnect

If the hex nuts are not tightened to specification, the driveshaft may disconnect from the drive axle, resulting in a loss of propulsion and increasing the risk of a crash.

HME will notify the owner, and a dealer will inspect the torque and if necessary tighten the bolts, free of charge. The recall began on February 24, 2016. Owners may contact HME customer service at 1-616-534-1463.

CPSC

Competition Off-road Motocross Motorcycles Recalled for Fire Hazard

The molded fuel hoses could leak fuel at the radius or the ends of the hose, posing a fire hazard.

Consumers should immediately stop riding the recalled motorcycles and contact an authorized KTM dealer to schedule a free repair. KTM is contacting consumers directly.

USDA Class I

Wegmans Food Markets Recalls Chicken Products Produced Without Benefit Of Inspection

Produced Without Benefit of Inspection

USDA Class I

Comeaux's Inc. Recalls Pork Products Due To Possible Listeria Contamination

Product Contamination

NHTSA

Wheel Chair Lift Link Arm Pivot Holes

If the bearings move out of position, the stowed platform may have excessive movement resulting in failure of the platform mounting. This failure could cause the wheel chair lift platform to fall out of the vehicle when the doors are opened, increasing the risk of injury for the lift operator.

Halcore will notify the owners, and Ricon dealers will inspect the link arms for damage or for displaced bearings. The platform will be inspected for cracks. Any damaged parts will be replaced, free of charge. The recall began on January 13, 2016. Owners may contact Ricon Customer Service at 1-800-322-2884 or AEV customer service at 1-800-374-9749. Halcore's number for this recall is 15E-068.

FDA

Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.

Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.

Invacare sent an Urgent Patient Safety Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their wheelchair povider to have their joystick replaced. Customers with questions were instructed to call their provider at Invacare's recall support line at 877-413-6008. Go to www.invacare.com/joystickrecall for more information regarding this recall

FDA

15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.

The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.

Baxter sent an Urgent Product Recall letter dated May 30, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. The recalling firm is instructing their customers to remove all affected products from their facility and quarantine the product subject to the recall. Customers are instructed to return the affected product to Baxter and receive a credit or replacement. For questions contact the Center for One Baxter at 1-800-422-9837.

USDA Class II

Huisken Meat Company Recalls Beef Products Due To Possible Foreign Matter Contamination

Product Contamination

FDA

Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

The labeling is missing the size/diameter information.

DJO Surgical sent an Urgent Field Safety Notice dated September 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested the consignees complete and return a response card and return affected devices for replacement. For further questions call (512) 832-6302.

FDA

MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.

The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.

Mentor sent an Important Labeling Correction letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm plans to follow-up with sales representative visits. The recall letter notifies the customer of the issue, but does not instruct them to return the product. Should the customer chose to return the product, all returned product will be tagged to denote no further distribution. The recalled units under firm control have been placed on hold in the inventory system. If you have any questions related to this notice, please contact your local Mentor Sales Representative, or Mentor Customer Service at 1-800-235-5731.

FDA

Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.

The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.

On 9/1/14 the recalling firm sent out a letter to their customers notifying them of an updated IFU for the recalled device. The letter also requested the customers to verify the quantity of the product they currently have on hand.