Archive
399 recalls were announced in April 2013.
Of the 399 recalls this month scored against our rubric, 5% are Critical, 17% are Severe.
Which agencies issued them
Kumho is recalling 11,922 Solus KH25 tires that were sold as used despite having drill holes, posing a risk of rapid air loss and crashes.
Westmor is recalling 2003-2013 trailers with specific Fisher pressure relief valves that may break and eject, posing injury and fire risks.
Prevost is recalling 416 parking brake chambers that may leak air, causing brakes to drag and overheat, which could result in a fire.
Jayco is recalling 2,491 recreational vehicles because a damaged awning motor may cause the awning to unfurl unexpectedly, increasing the risk of injury or a crash.
Mercedes-Benz is recalling 2013 GL350, GL450, GL550, and GL63 vehicles because second-row seat belt anchor bolts may not be properly torqued, increasing injury risk in a crash.
MTD Products is recalling about 2,100 Cub Cadet 2011 commercial zero turn mowers because fuel can leak from the tank, posing a fire risk.
Winnebago is recalling specific 2013-2014 motorhomes because an awning motor defect may cause the awning to unfurl unexpectedly, increasing the risk of injury or a crash.
HME is recalling 11 fire apparatus vehicles because parking brake chambers may leak, causing brakes to drag and overheat, which could result in a fire.
Setra is recalling 2011-2013 S417 TC and 2012-2013 S407 motorcoaches because moisture in the engine compartment can cause electrical corrosion and potential fire.
The Land of Nod is recalling about 2,500 plush handmade baby dolls because their hands can detach, posing a choking hazard to young children.
Currey & Company is recalling specific chandeliers because defective wiring can conduct electricity to metal parts, posing an electric shock hazard.
Toyota is recalling 2007-2013 FJ Cruiser vehicles equipped with specific auxiliary lamp kits because the 55-watt bulbs exceed federal brightness limits, increasing glare and crash risk.
Cequent is recalling Pro Series Translite Bike Racks because cradles may tear, allowing bikes to fall onto the roadway and create a crash hazard.
3T Design is recalling specific Cervélo bicycles because the handlebar clamps can detach, causing the rider to lose control and potentially be injured.
Thor Motor Coach is recalling specific 2013-2014 motorhomes because an awning motor defect could cause the awning to unfurl unexpectedly, increasing the risk of injury or a crash.
Body Basics Inc is recalling Actra-SX 500 capsules because they contain sildenafil, an active ingredient in FDA-approved erectile dysfunction drugs, without an approved NDA or ANDA.
Hospira is recalling 143,136 units of Lactated Ringer's and 5% Dextrose Injection due to confirmed mold contamination.
Little Mermaid Smokehouse is recalling smoked herring found to be uneviscerated during an FDA inspection due to the potential for Clostridium botulinum.
Publix Super Markets is recalling specific 12oz containers of Deli Tri Fruit and Grain Salad because the product may be adulterated with Listeria monocytogenes.
The Menz Club is recalling Blue Male Enhancement Pill because it contains sulfoaildenafil, an unapproved analogue of sildenafil.
Brand New Energy, LLC is recalling EphBurn 25 supplements because they may contain ephedrine alkaloids, making them unapproved drugs.
Little Mermaid Smokehouse is recalling pickled herring found to be uneviscerated during an FDA inspection due to the potential for Clostridium botulinum.
Hospira is recalling Lactated Ringer's and 5% Dextrose Injection due to a confirmed report of non-sterility involving spore-like particulates consistent with mold.
Teva Pharmaceuticals is recalling 6,692 boxes of Copaxone (glatiramer acetate) injection due to visible medical grade silicone oil in the syringes.
SR Instruments is recalling 806 FG3105 patient scales used with Joerns Healthcare lifters after two load cell failures caused patient falls.
La Preferida Inc is recalling 57,040 cans of pinto beans because some may not have been fully processed, posing a risk of illness from spoilage organisms or pathogens.
Subaru is recalling 2014 Forester vehicles because floor mats may curl and interfere with pedals, posing a crash risk.
Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, causing the device to deliver too much medication.
Advanced Sterilization Products is recalling 761 EVOTECH Endoscope Cleaner and Reprocessor systems because a circuit board malfunction can cause smoke to emanate from the device.
Stryker Orthopaedics is recalling ShapeMatch Cutting Guides used in knee surgeries due to potential issues with internal planning and production processes.
Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, potentially causing over-infusion of medication.
Winnebago is recalling 2012-2014 motorhomes because a missing range enclosure may allow propane gas to flow without a flame, creating a fire hazard.
Accuray Incorporated is recalling 176 Iris Variable Aperture Collimators for the CyberKnife System due to a defect that could shift the radiation beam's central axis.
GE Healthcare is recalling Muse v7 cardiology systems because they may display incorrect medications, potentially leading to incorrect patient treatment.
Honda is recalling 91,920 2012-2013 Fit vehicles because the electronic stability control system may allow excessive yaw rates, increasing crash risk.
Biomet U.K., Ltd. is recalling 430 Oxford Uni Knee System Toffee Hammers because excessive use may cause the head to detach from the handle.
Heritage Labs is recalling 25 Path Study Extra Supplies Kits because they contain blood collection tubes with a Lithium Heparin contaminant that could cause erroneous lab results.
Edwards Lifesciences is recalling 6,117 units of Model 9100CR26 Crimpers because holes in the sterile barrier pouch may compromise sterility.
Zumbro River Brand is recalling Ideal Protein BBQ Ridges because a flour ingredient may contain fine wire pieces.
Fresh & Easy is recalling Organic 100% Apple Juice from concentrate because it may be contaminated with patulin. The product was distributed in California, Arizona, and Nevada.
Maquet is recalling 154 Cardiohelp Support Systems because the touch screen display may shut down unexpectedly and restart automatically.
Elana, Inc. is recalling three Elana Catheter Sizer 2.0 devices because they were distributed in interstate commerce without FDA approval.
Terex is recalling 1998-2005 OM Aerial Devices because fatigue cracks in the leveling arm may cause failure, risking injury to operators.
Tristar Food Wholesale Company Inc. is recalling 400g bags of Dried Medlar because the product contains undeclared sulfites.
Edwards Lifesciences is recalling 5,472 units of Model 9100CR23 Crimpers because holes in the sterile barrier pouch may compromise sterility.
Reed and Barton is recalling Gingham Bunny baby flatware because the pink coloring on the bunny ears can come off, posing choking and ingestion hazards.
Transonic Systems Inc. is recalling HCS3011 and HCS3021 AV Loop Kits due to complaints of blood leakage. The kits are used for cardiovascular status assessment.
EndoGastric Solutions is recalling 190 EsophyX2 Plus devices used to treat GERD because they were not validated under actual or simulated use conditions before distribution.
Siemens is recalling Vista Drug 4 Calibrators because they cause low digoxin test results, potentially affecting patient care.
Edwards Lifesciences is recalling 379 units of Duraflo coated Femoral Cannula because two unsealed pouches were found at a distribution location, posing a sterility risk.
Lifescan is recalling OneTouch Verio IQ Blood Glucose Meters because they shut off instead of displaying 'EXTREME HIGH GLUCOSE' at high readings.
Roche is recalling CoaguChek XS Pro meters and Accu-Chek Inform II barcode scanners because they may incorrectly decode patient identification barcodes.
GE Healthcare is recalling AW Server software due to a defect where patient data from one individual may be displayed in the Results Viewer for a different patient.
Target is recalling Giada De Laurentiis ceramic lasagna pans because they can break, creating sharp edges that pose a laceration hazard.
Zumbro River Brand is recalling Ideal Protein Sea Salt & Vinegar Ridges because a flour ingredient may contain fine wire pieces.
Siemens Medical Solutions is recalling syngo WorkFlow SLR software due to a defect that may display the wrong patient's documents in signed reports.
GE Healthcare is recalling 48 Innova IQ systems manufactured between March 2010 and July 2011 because a safety label is missing from the gantry pivot section.
Roche Diagnostics is recalling Accu-Chek Inform II and CoaguChek XS Pro barcode scanners because they may intermittently misread patient identification barcodes.
Nissan is recalling 2013 Altima vehicles because the spare tires may be significantly over- or under-inflated, which could lead to tire failure and increase the risk of a crash.
Acist Medical Systems is recalling 6,640 units of BT2000 Automated Manifold Kits due to air ingress into the manifold body.
Carefusion is recalling 4,090 Alaris PC unit model 8015 devices with software version 9.12 due to potential data loss risks during bolus programming.
Advanced Sterilization Products is recalling 273 EVOTECH Endoscope Cleaner & Reprocessor Systems because they did not receive sufficient High Potential (HIPOT) DC voltage testing.
Philips is recalling IntelliSpace Portal software version 4.0.2 due to a display error when using URL PACS integration. The issue causes the Review monitor to display incorrect patient studies.
Children's Apparel Network is recalling Young Hearts girl's clothing sets because the vest's waist belt poses an entrapment hazard. No injuries have been reported.
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because extension springs may be out of specification, potentially causing imprecise chemistry test results.
Horiba Medical is recalling ABX PENTRA 400 I.S.E. Modules because the software lacks Linearity Limit Flags for I.S.E. assays, which may prevent users from detecting out-of-range values.
Lifescan Inc is recalling OneTouch Select Control Solution because it may cause blood glucose meters to display results outside the expected range, even when the system is working properly.
DeGotzen is recalling 159 XGenus dental X-ray units because method samples failed labeling and certification requirements.
Two Chefs on a Roll is recalling Trader Joe's Spicy Hummus Dip because it may contain small pieces of food grade equipment material.
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because extension springs may be out of specification, potentially causing imprecise test results.
Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after the package is opened.
Smith & Nephew is recalling 23 units of 4.5 mm Trigen bone screws that were incorrectly anodized with a gold coating instead of gray.
Pfizer is recalling specific lots of Levoxyl (levothyroxine sodium) tablets because they emit a strong chemical odor after the package is opened.
Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after opening. Consumers should stop using the affected products.
Alere San Diego is recalling 38,571 ALT AST test cassettes because humidity changes may impact test results.
Pfizer is recalling Levoxyl (levothyroxine sodium) tablets because they emit a strong odor after the package is opened.
Philips Healthcare is recalling CT systems because CTDI measurements were 15 to 25% higher than protocol parameters.
Integra LifeSciences Corp. is recalling XKnife software versions 5.0.1 and 5.0.2 due to a software error that may occur when transmitting beam plans.
Bacterin International is recalling 165 units of OsteoSelect DBM Putty because the firm's retesting procedure was not validated.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient samples.
Synvasive Technology is recalling 100 kits of Oxford Partial Knee Resection Procedure 3 Packs because they contained the incorrect surgical blade.
Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots due to imprecision issues that increase with the age of the reagent.
Nestle Puerto Rico Inc is recalling Gerber Pure Water (1 Plastic Gallon) after an audit found mold and deficiencies in the ozone purification system.
Nipro Diagnostics is recalling 1,627 TRUEtrack monitor kits because the outer boxes state an incorrect storage temperature range for the test strips.
Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after the package is opened.
Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after opening. The recall covers 10,121 bottles distributed nationwide and in Puerto Rico.
Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong odor after the package is opened.
Pfizer is recalling specific lots of Levoxyl tablets because they emit a strong chemical odor after the package is opened.
Pfizer is recalling Levoxyl (levothyroxine sodium) tablets because they emit a strong odor after the package is opened.
Pfizer is recalling Levoxyl (levothyroxine sodium) tablets because they emit a strong odor after the package is opened.
Two Chefs On A Roll is recalling Trader Joe's Chunky Olive Hummus because it may contain small pieces of food grade equipment.
L. K. Bowman is recalling 3,480 #10 cans of Brights mushrooms due to isolated spoilage. The product was distributed to one firm in Utah.
Vital Images is correcting a defect in the Vitrea CT Multi-Chamber Cardiac Functional Analysis application where numerical values in the Results Table may be incorrect.
Intuitive Surgical is recalling IS2000 user manuals for the da Vinci S system to provide revised instructions on sterile adapter engagement and instrument installation.
Edwards Lifesciences is recalling Pressure Monitoring sets with VAMP Plus closed blood sampling systems due to incorrect assembly that may dilute blood samples.
Two Chefs on a Roll is recalling Trader Joe's Hummus Salad Dressing because it may contain small pieces of food grade equipment.
Precision Dose Inc. is recalling Children's Acetaminophen Oral Suspension because the label is misleading. The product contains an adult dose of acetaminophen despite the name.
Miami Growers, Inc. is recalling Siya Green Mukwhas because the product contains unapproved and undeclared colors.
Two Chefs On A Roll is recalling Trader Joe's Roasted Garlic Hummus Dip because it may contain small pieces of food-grade equipment material.
Two Chefs on a Roll is recalling Trader Joe's Mediterranean Hummus because it may contain small pieces of food-grade equipment material.
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