Archive
533 recalls were announced in June 2013.
Of the 533 recalls this month scored against our rubric, 5% are Critical, 33% are Severe.
Which agencies issued them
Best Buy is recalling ATG replacement batteries for MacBook Pro computers because they can catch fire while charging, posing fire and burn risks.
Kolcraft is recalling Jeep Liberty strollers because tire inner tubes can rupture, causing wheel rims to fly off as projectiles. The defect has resulted in 18 reported injuries.
Pure Herbs, Ltd. is recalling Natural Herbal Extracts Protein Dietary Supplement bottles because they contain undeclared milk and soy allergens, posing a risk of serious allergic reactions.
Trophy Nut Co Inc is recalling 6 oz. natural pistachios because they were made with pistachios that may be contaminated with Salmonella.
OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.
Edwards Lifesciences is recalling QuickDraw Venous Cannulas because the device may separate during withdrawal when using the percutaneous insertion method.
DePuy Orthopaedics is recalling Glenosphere orientation guides because an etched arrow is on the wrong side, which could lead to incorrect implant alignment.
Bard Peripheral Vascular is recalling 815 UltraClip breast tissue markers because they were distributed without completing the sterilization process.
Bard Peripheral Vascular is recalling UltraClip breast tissue markers because the metal marker may separate from the needle before use.
OrthoPediatrics Corp is recalling 130 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.
Bard Peripheral Vascular is recalling 315 UltraClip breast tissue markers that were distributed without completing the sterilization process.
Endologix Inc. is voluntarily recalling 53 units of the AFX Introducer System due to reports of dilator breakage during clinical procedures.
XYMOGEN Artriphen joint supplement is being recalled because the label fails to declare soy and milk, posing a risk to allergic consumers.
Purely American, Inc. is recalling 73 bags of Gilroy Garlic Pasta Stir Fry Mix because the labels are missing the required wheat allergen declaration.
Applied Medical is recalling specific lots of Epix and Direct Drive Laparoscopic Graspers because the trigger may fracture, potentially leaving the jaws closed.
Polaris is recalling about 4,500 2011 Ranger RZR XP 900 off-highway vehicles because the firewall can overheat and melt, posing a burn risk.
Purely American, Inc. is recalling Chicken Noodle Soup Mix because some labels are missing the required wheat allergen declaration.
American Importing Co, Inc is recalling Market Pantry Sweet & Salty Mix because it contains Butter Toffee Peanuts with undeclared milk.
Abbott Medical Optics is recalling STAR S4 Excimer Laser Systems due to an unlikely potential for inadvertent laser firing under specific conditions.
Whole Foods Market is recalling Natures Path Hemp Plus Granola sold in bulk bins because it may contain undeclared almond slices.
Abbott Medical Optics is recalling 1,882 STAR S4 IR Excimer Laser Systems worldwide due to an unlikely potential for inadvertent laser firing under specific conditions.
Easton is recalling specific batches of Axis archery arrows because they can break when fired, posing a risk of injury to users and bystanders.
Purely American, Inc. is recalling Indian River Orange Drop Cookies Mix because the labels are missing the required wheat allergen declaration.
Bard Peripheral Vascular is recalling 17 MicroSheath and Usher support catheters because they were distributed without completing the sterilization process.
Abbott Medical Optics is recalling STAR S3 Excimer Laser Systems due to an unlikely potential for inadvertent laser firing under specific conditions.
Purely American, Inc. is recalling specific 10 oz bags of Pasta Salad Mix because the labels are missing the required wheat allergen declaration.
Ethicon Endo-Surgery is voluntarily recalling Echelon 60mm endoscopic linear cutter reloads worldwide due to potential reload damage that could cause incomplete staple line formation.
Purely American, Inc. is recalling Santa Fe Cornbread Mix because the labels are missing the required wheat allergen declaration.
Bard Peripheral Vascular is recalling 223 Usher Support Catheters that were distributed without completing the sterilization process.
Southwest Ice Cream Specialties is recalling 1,524 cartons of ice cream because the product may contain undeclared pecan, soy, and/or wheat allergens.
OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.
Purely American, Inc. is recalling Adirondack Getaway Pasta Toss Mix because some labels are missing the required wheat allergen declaration.
International Desserts is recalling Uncle Eddies Vegan Oatmeal Chocolate Cookies because they may contain undeclared walnuts.
Purely American, Inc. is recalling Shenandoah Valley Apple and Spice Cake Mix because some labels are missing the required wheat allergen declaration.
Purely American, Inc. is recalling 413 bags of Mama Marino's Minestrone Soup Mix because the labels are missing the required wheat allergen declaration.
Dairy Fresh LLC is recalling IGA Brand Vanilla & Chocolate Ice Cream because it contains undeclared almonds, coconut, and soy lecithin.
Purely American, Inc. is recalling 15 oz bags of Long Island Baymen Seafood Chowder Mix because the labels are missing the required wheat allergen declaration.
Purely American, Inc. is recalling specific varieties of Pasta Salad Mix because the labels are missing the required wheat allergen declaration.
Siemens Healthcare Diagnostics is recalling MicroScan Dried Negative Breakpoint Combo 47 panels due to potential false negative or delayed Arginine results.
Utah Medical Products is recalling 1,800 Deltran Disposable Pressure Transducer Kits due to complaints regarding the packaging integrity of the sterile devices.
International Biomedical is recalling VIA Medical Collection Bags because the connector can become occluded if the luer lock is over-tightened.
Embla System LLC is recalling 519 Embletta Gold polysomnography recorders due to a calibration error that may lead to over-titration of sleep therapy.
Bard Peripheral Vascular is recalling Vaccess PTA Balloon Dilatation Catheters because the inflation hub may display an incorrect balloon diameter.
Purely American, Inc. is recalling Marin County Carrot Cake Mix because the labels are missing the required wheat allergen declaration.
American Optisurgical is recalling TX1 Tissue Removal System disposable handpieces because they were distributed without a cleared FDA 510(k) for recent product changes.
Dental EZ Stardental Division is recalling 3,560 StarDental Classique Diamond Dental Burs because a manufacturing issue prevented the diamond coating from adhering properly to the shank.
Fenwal is voluntarily recalling 114 AMICUS Exchange Kits because the product was cleared for European use only but distributed in the US.
Teva Pharmaceuticals is recalling Amoxicillin for Oral Suspension due to yellow to brown discoloration on the inner foil seal.
Actavis is recalling Fentanyl Transdermal Systems, 50 mcg/h, because they failed impurities and degradation specifications.
Berkshire Cheese LLC is recalling Berkshire Blue Cheese due to non-pathogenic E. Coli contamination. The product was distributed in Massachusetts.
Forest River is recalling 289 model year 2014 Sunseeker, Forester, Lexington, and Solera motorhomes because a battery isolation manager short circuit could cause smoke or fire.
Buy Buy Baby is recalling Idea Baby bath seats because they can tip over, posing a drowning risk to infants. No injuries have been reported.
BeBeLove is recalling about 5,600 E-Zee Bath Seats because they can tip over, posing a drowning risk to babies. No injuries have been reported.
Chelsea & Scott is recalling Idea Baby Bath Seats because they can tip over, posing a drowning hazard to infants.
Sam's Club is recalling Metro and Montero outdoor seating groups because swivel bases can break, posing a fall hazard. No injuries have been reported.
Hammacher Schlemmer is recalling 92 teak shower stools because the wood seat can break, posing a fall hazard. No injuries have been reported.
Tesla is recalling 1,228 2013 Model S vehicles because a weakened weld on the left second-row seat back may cause it to detach in a crash, increasing injury risk.
Honda is recalling specific 2006-2007 S2000 and 2006 Acura RSX vehicles because the brake booster may lose vacuum, reducing braking assistance and increasing crash risk.
North American Bus Industries is recalling 2003-2013 45CLFW and 2013 40CLFW transit buses because the air brake pedal mounting may become loose, increasing crash risk.
Texsport is recalling about 325 Cedar Lake Propane Heater/Cookers because a malfunctioning regulator can cause propane to flare, posing a fire hazard.
Temsa is recalling 256 motorcoaches because over-tightened seat belt bolts may fail in a crash, increasing injury risk.
General Motors is recalling approximately 193,652 vehicles from 2005-2007 due to a driver's door module defect that could cause a fire.
Stride Rite is recalling about 7,500 'Joanna' girl's sandals because the metal flower on top can detach, posing a choking hazard to children.
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 because they may deliver excessively high flow rates.
Symbios Medical Products is voluntarily recalling GoPump kits because some units may deliver excessively high flow rates.
Whole Foods Market Group Inc. is recalling 493 lbs of Salad Chicken Curry due to an undeclared egg allergen. The product was sold in six northeastern states.
TG United, Inc. is recalling 386 bottles of TG 40PSE/400GFN tablets because they are underdosed or have an incorrect dosage regime.
Pentec Health is recalling Baxter LL bag 1% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
Pentec Health is recalling Baxter LL bag 1.5% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
Symbios Medical Products is voluntarily recalling GoPump infusion pumps and kits due to reports of excessively high flow rates.
The Compounding Shop is recalling MIC + B12 injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
TG United, Inc. is recalling CPM / PSE DM Drops because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling BroveX PSE DM bottles because they are underdosed or have an incorrect dosage regime.
Pentec Health is recalling Proplete 52 intradialytic parenteral nutrition bags because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
Pentec Health is recalling 9 bags of Proplete 40 intradialytic parenteral nutrition due to a lack of assurance of sterility.
TG United, Inc. is recalling Ryddex G Tablets because they are underdosed or have an incorrect dosage regime. The recall affects 2,957 bottles distributed in five states.
TG United, Inc. is recalling Maxifed DM tablets because they are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling specific lots of Trigofen Drops because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling 348 bottles of AMBI cold and flu syrup due to CGMP deviations resulting in underdosed products.
The Compounding Shop is recalling Mitomycin 0.3 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
Pentec Health is recalling Baxter LL bag 2% Amino Acids because sterility could not be assured for the compounded sterile renal nutritional prescriptions.
TG United, Inc. is recalling 22,721 bottles of Brompheniramine/Pseudoephedrine DM liquid because the product is underdosed or has an incorrect dosage regime.
TG United, Inc. is recalling Cardec DM Drops because the products are underdosed or have an incorrect dosage regime.
TG United, Inc. is recalling specific lots of AMBI 40PSE/400GFN/20DM cough suppressant and expectorant bottles due to CGMP deviations resulting in underdosed products or incorrect dosage regimes.
Pentec Health is recalling Baxter LL bag 1% Amino Acids w/KCL because sterility could not be assured for these compounded sterile renal nutritional prescriptions.
The Compounding Shop is recalling Glutathione 200 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
TG United, Inc. is recalling ZoDen PD nasal spray bottles because the products are underdosed or have an incorrect dosage regime.
Kreg Medical Inc. is recalling 59 E-Z Wider Bariatric Chair Beds because the bed frame collapsed during patient use, leaving the patient in a forward tilt position.
TG United, Inc. is recalling 2,388 bottles of Z-Dex Syrup because the product is underdosed or has an incorrect dosage regime.
The FDA is recalling 23,050 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially causing components to enter the patient's cavity.
TG United, Inc. is recalling Poly-Vent DM Tablets because the products are underdosed or have an incorrect dosage regime.
Pentec Health is recalling Proplete 80+ KG renal nutritional prescriptions because sterility could not be assured for the compounded sterile products.
The FDA is recalling 5,364 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially allowing components to enter the patient's cavity.
TG United, Inc. is recalling 355 bottles of AMBI antihistamine and nasal decongestant syrup due to CGMP deviations resulting in underdosed products.
TG United, Inc. is recalling 40,149 bottles of Trigofen DM Drops because the products are underdosed or have an incorrect dosage regime.
The Compounding Shop is recalling Lipoic Acid 25 mg/mL Injectable vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The Compounding Shop is recalling Testosterone Cypionate 200 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
Intuitive Surgical is recalling approximately 132,441 EndoWrist Monopolar Curved Scissors instruments worldwide. The recall addresses potential cracks that may cause electrosurgical energy leaks and thermal injury to tissue.
Pentec Health is recalling Baxter Ultrabag 1.5% Amino Acids because sterility could not be assured for compounded sterile renal nutritional prescriptions.
TG United, Inc. is recalling 1,623 bottles of Maxifed-G tablets because the products are underdosed or have an incorrect dosage regime.
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