Archive
530 recalls were announced in September 2013.
Of the 530 recalls this month scored against our rubric, 3% are Critical, 38% are Severe.
Which agencies issued them
University Compounding Pharmacy is voluntarily recalling PGE-1, 20 mcg/mL Injection in Normal Saline due to lack of assurance of sterility.
Leica Microsystems is recalling 28 surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.
GE Healthcare is recalling Tec 6 and Tec 6 Plus anesthesia vaporizers because the pre-operative leak test may fail to detect leaks caused by seal wear.
University Compounding Pharmacy is voluntarily recalling PGE-1 injections due to lack of assurance of sterility. The recall affects nationwide distribution.
New Sun Inc. is voluntarily recalling JLB Combination dietary supplements due to positive E. coli test results.
FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water while labeled as saline or heparin.
Siemens Healthcare Diagnostics is recalling 488 units of ADVIA Centaur Folate reagent due to calibration failures and quality control shifts.
Xlumena is recalling 148 units of the NAVIX Access Device because a complaint investigation found the catheter can fracture at the distal end under load.
Roche Molecular Systems is recalling specific lots of cobas 4800 HPV test kits because a formulation error was identified during the manufacture of the Master Mix reagent.
CareFusion is recalling Thoracentesis and Safe-T Thoracentesis Trays because the included catheters may occlude, potentially delaying medical procedures and causing patient complications.
Nissan is recalling 2013 Armada and Titan vehicles because a brake master cylinder defect may reduce front brake pressure, increasing the risk of a crash.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.
Lumenis is recalling three Vision One Laser Systems due to a potential for unintended laser exposure to the user.
Beacon Hill Medical Pharmacy is recalling Sermorelin Acetate 10 mg injectable because FDA inspectional findings raised concerns about sterility assurance and quality control.
B. Braun Medical is recalling 900 Outlook Safety Infusion System Burette Sets because one injection site and valve were assembled upside down.
Beacon Hill Medical Pharmacy is recalling Methylcobalamin injections because FDA inspections found quality control issues that impacted sterility assurance.
Craftsmen is recalling 2006-2013 custom vehicles with Fastec door locks that may jam, potentially trapping occupants inside the vehicle.
Hospira Inc. is recalling 283,150 vials of Propofol Injectable Emulsion because visible particulate matter was found embedded in the glass vials during inspection.
Edwards Lifesciences is recalling 35 units of the FloTrac Sensor Model MHD85 because incorrect packaging configuration prevents validation of the product's sterility.
Medical Indicators, Inc. is recalling Tempa DOT single-use clinical thermometers due to potential mislabeling. The recall affects 111,800 boxes distributed nationwide.
HemoCue AB is recalling HemoCue Glucose 201 Microcuvettes because some single-pack pouches were found to be punctured during a complaint investigation.
Stonyfield Farm is recalling 1,680 cups of Organic O Soy Yogurt Strawberry due to coliform levels exceeding product specifications.
University Compounding Pharmacy is voluntarily recalling Testosterone CYP (Sesame Oil) 200mg/mL Injection due to lack of assurance of sterility.
Qualitest Pharmaceuticals is recalling 1,680 boxes of effervescent potassium chloride tablets because they may be mislabeled as a different potassium product.
Qualitest Pharmaceuticals is recalling 1,680 boxes of K Effervescent Tablets because they may be mislabeled as Potassium/Chloride Tablets.
Advanced Sterilization Products is recalling 1,923 STERRAD 100NX Cassettes because it lacks adequate data to support the packaging's leak indicator effectiveness for the full 15-month shelf life.
Baxter Healthcare is voluntarily recalling one lot of Baxa Vial Adapters due to an incorrect expiry date.
Waterlogic is recalling about 48,000 chiller-based water dispensers because the hot water tank can stop functioning and cause the machine to overheat, posing a fire hazard.
Pierce is recalling 2012-2013 Velocity and Arrow XT emergency vehicles because a valve defect may prevent parking brakes from engaging, increasing crash risk.
Newmar is recalling 2012 Essex and King Aire motor homes because air pressure gauges may be inaccurate, potentially hiding low air brake pressure and increasing crash risk.
The Children's Place is recalling about 38,000 footed pajamas in the U.S. because they fail federal flammability standards, posing a burn hazard to children.
Chalet RV is recalling 2006-2013 travel trailers and truck campers because a door lock defect could jam the deadbolt, trapping occupants inside.
Augusta RV is recalling 189 FLEX recreational vehicles because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.
Vactor is recalling 2012-2013 Ramjet vehicles with Allison Transmissions because incorrect software may allow the vehicle to enter drive mode while the power take-off is in use.
Cowtown Sleepers is recalling 2008-2013 truck sleepers because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.
Hart Trailer LLC is recalling 2006-2013 Medallion, Ultimate, and Cargo horse trailers because a door lock defect may jam, trapping occupants inside.
PROLine is recalling 2006-2013 travel trailers with Fastec door locks that may jam, potentially trapping occupants inside the vehicle.
Arising Industries is recalling 2008-2013 cargo trailers because a door lock defect may jam the deadbolt, trapping occupants inside.
Coose Trailer is recalling 2006-2013 travel trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside.
Horton Vans is recalling 2006-2013 cargo trailers with Fastec door locks that may jam, potentially trapping occupants inside.
Pleasant Valley is recalling 2006-2013 travel trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.
Adventurer LP is recalling 2009-2012 truck campers because a door lock defect may jam the deadbolt, trapping occupants inside the vehicle.
Gree is recalling 12 brands of dehumidifiers due to fire and burn hazards. Consumers should unplug the units and contact Gree for a refund.
Mitsubishi Fuso is recalling 2013-2014 FEC52, FEC72, FEC92, and FGB72 trucks because transmission oil cooler hoses may leak fluid, potentially causing the transmission to fail and increasing crash risk.
Terex is recalling 1997-2013 XT55 and XT60 aerial devices because cracks in the boom hinge may cause the platform to fall, risking injury.
Genie is recalling 3,889 TZ-34 aerial work platform trailers because the outrigger assembly may not stay stowed during transport, increasing crash risk.
Lakota is recalling two 2007 travel trailer models because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.
Dolan Designs is recalling about 8,000 ceiling-mounted light fixtures because degraded wire insulation can expose charged wires, creating fire and electric shock risks.
Cimarron Trailers is recalling 2006-2012 livestock trailers because a door lock defect could jam the deadbolt, potentially trapping occupants inside.
Champion Bus is recalling 598 buses from 2009-2011 because voltage spikes may damage door header circuit boards, increasing the risk of a fire.
Beamonstar Products is recalling SexVoltz All Natural Herbal Supplement because it contains tadalafil, an unapproved drug ingredient.
Zip International Group LLC is recalling Baltic Sprats in Spicy Brine because the product may be contaminated with Listeria monocytogenes.
Beamonstar Products is recalling Velextra All-Natural Herbal Supplement because it contains tadalafil, an unapproved drug ingredient.
Conagra is recalling Kroger Break 'N Bake Chocolate Chip Cookie Dough because peanut butter was present but not listed on the label.
Saratoga Therapeutics is recalling ebA Multivitamin tablets because they contain milk components despite labeling stating they are free of milk.
Dove Chocolate Discoveries is recalling 18 oz boxes of Fruit Collection Dark Chocolate due to mislabeling. The boxes contain Cinnamon Dusted Dark Chocolate Almonds instead of the labeled fruit mix.
Terrafina is recalling specific varieties of salted pistachios due to potential Salmonella contamination. The products were distributed in New York, New Jersey, and Florida.
Terrafina is recalling five varieties of unsalted pistachios due to potential Salmonella contamination. The products were distributed in New York, New Jersey, and Florida.
Yamaha is recalling 320 model year 2011 Vino Classic motorcycles because brake shoe linings may separate, reducing brake performance and increasing crash risk.
Teva Pharmaceuticals is recalling CARBOplatin Injection because the required reduction of endotoxin was not met during annual revalidation of the vial washer.
The Warrell Corporation is recalling chocolate covered peanuts mislabeled as raisins because the peanut allergen is not identified on the packaging.
Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers 660 units distributed worldwide.
Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 220 units distributed worldwide.
Stelkast Co is recalling 11 units of SC2316 Distal Femoral Augments with Screws due to a breach of sterility in the packaging.
Visonic is recalling about 24,000 Amber PERS kits because base stations in Common Area Mode may fail to detect low pendant batteries. No injuries have been reported.
Genzyme is recalling 110 units of LeGoo Endovascular Occlusion Gel 0.5 mL because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.
Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 250 units distributed worldwide.
BMW is recalling 2008-2010 528i, 535i, 550i, and M5 vehicles because increased electrical resistance may cause rear lamp failure, reducing visibility to other drivers.
Thrive Foods is recalling 6 Grain Pancake Mix because ingredients react over time, increasing can pressure and the risk of injury when opened.
L.L.Bean is recalling Deluxe Packaway Boat Carts because plastic wheel rims can burst when tires are over-inflated, posing an injury risk.
Genzyme Corporation is recalling 776 units of LeGoo Internal Vessel Occluder because the product contains particulates (fibers). The recall covers units distributed worldwide.
Genzyme is recalling LeGoo Internal Vessel Occluder 5mL units because they contain fiber particulates. The recall covers 308 units distributed worldwide.
The Seafood Exchange of Florida is recalling H-E-B Jumbo Butterfly Shrimp because the product contains coconut, which is not listed on the label.
Genzyme is recalling LeGoo Internal Vessel Occluder devices because they contain particulates (fibers). The recall affects 448 units distributed worldwide.
MicroAire Surgical Instruments is recalling Steinmann Pins because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.
Genzyme Corporation is recalling 65 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers lots distributed worldwide.
Hachette Book Group is recalling two children's board books because a metal rod with beads can detach, posing choking and laceration risks.
Genzyme Corporation is recalling 652 units of LeGoo Internal Vessel Occluder because the product contains particulates (fibers). The recall covers units distributed worldwide.
Genzyme Corporation is recalling 37 units of LeGoo Internal Vessel Occluder 10mL because the product contains particulates (fibers). The recall covers units distributed worldwide.
MicroAire Surgical Instruments is recalling Kirschner-Wires because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.
Cambridge Metal and Plastics is recalling Moose Racing brand motorcycle training wheels because bolts and nuts can loosen, causing the rider to lose control and crash.
Tortillas Lupita Flour Tortillas are being recalled because they contain undeclared soy lecithin and soybean oil.
DePuy Spine is recalling Confidence Spinal Cement System Kits because hydraulic pump leaks can cause loss of pressure during cement injection.
Genzyme Corporation is recalling 181 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry A1c_3 Calibrators because they cause a positive bias of up to 12% in HbA1c test results.
Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers 100 units distributed worldwide.
Genzyme Corporation is recalling 331 units of LeGoo Internal Vessel Occluder 2.5mL because the product contains particulates (fibers). The recall covers units distributed worldwide.
Genzyme is recalling 45 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.
DePuy Spine is recalling Confidence Spinal Cement System 5cc kits because hydraulic pump leaks can cause loss of pressure during injection.
Elekta, Inc. is recalling 31 DMLC IV-ERGO beam shaping blocks used in radiation therapy due to potential clinical mistreatment from workflow errors or incorrect settings.
Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 5 units distributed worldwide.
Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 30 units distributed worldwide.
Justin's Nut Butter is voluntarily recalling specific lots of Maple Almond Butter and Chocolate Hazelnut Butter due to the presence of foreign metallic fragments.
DePuy Spine is recalling the Confidence Spinal Cement System 11CC Plus Kit because water leaks in the hydraulic pump cause pressure loss, preventing cement injection.
Boston Scientific is recalling 4.0mm x 15mm Small Peripheral Cutting Balloon catheters because users may be unable to remove the protector cap from the device.
Genzyme Corporation is recalling 994 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers units distributed worldwide.
Potters Fine Foods is recalling 109 packages of Classic White Crackers due to cross-contamination with a walnut-containing dough.
Crown Pacific International is recalling sweet and Thai basil due to a Hawaii cease and desist order for positive pesticide samples.
Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel 2.5 mL because the product contains particulates (fibers). The recall covers 100 units distributed worldwide.
Contoocook Creamery is recalling salted butter in 8oz tubs and 5-gallon pails due to elevated coliform and standard plate counts.
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