Archive
875 recalls were announced in August 2012.
Of the 875 recalls this month scored against our rubric, 18% are Critical, 40% are Severe.
Which agencies issued them
Breadfarm is recalling specific wheat crackers because the wheat germ used may contain metal fragments. The contamination occurred at the raw ingredient manufacturer.
AGFA Corp. is recalling IMPAC and IMPAX CV DICOMStore devices because misconfiguration may cause loss of patient data.
Terumo is recalling 232 interface modules for the CDl System 100/101 due to reported data transfer malfunctions and smoke odors.
Exactech, Inc. is recalling 70 Optetrak Proximal Tibial Spacers because they are dimensionally incompatible with the Logic Tibial Tray.
Winn-Dixie is recalling Southern Home Cranberry Nut Antioxidant Blend trail mix because it contains undeclared soy lecithin.
Breadfarm is recalling Whiskey Pecan Cookies because the wheat germ used in the dough was potentially contaminated with metal fragments.
KT Specialty Foods Inc. is recalling 20 units of bulk Veggie Pizza in Oregon and Washington because the product lacked temperature control, posing a risk of pathogen growth.
Two Moms in the Raw is recalling Pesto Sea Crackers because the pine nuts used may contain peanuts, posing a risk to individuals with peanut allergies.
Beckman Coulter is recalling UniCel DxI 800 Access Immunoassay Systems because a software anomaly may cause erroneous test results.
Flywheel's Pies is recalling Raisin Pies sold in Arkansas due to undeclared partially hydrogenated soybean oil and wheat.
Flywheel's Pies is recalling coconut pies sold in Arkansas due to undeclared soy lecithin, soybean oil, and wheat.
Beckman Coulter is recalling UniCel DxI 600 Access Immunoassay Systems because a software anomaly may cause erroneous test results.
Flywheel's Pies is recalling Peach Pies sold in Arkansas due to undeclared soy lecithin, partially hydrogenated soybean oil, and wheat.
Philips is recalling 126 CT systems because a damaged foot switch cover may cause the patient support to move unexpectedly.
Flywheel's Pies is recalling apple pies sold in Arkansas due to undeclared soy lecithin, partially hydrogenated soybean oil, and wheat.
Hitachi is recalling MRI software due to a defect that may reverse the orientation of the first image in a dataset.
KT Specialty Foods Inc. is recalling Cheese Pizza in Oregon and Washington because it was not kept at safe temperatures to prevent pathogen growth.
Flywheel's Pies is recalling Lemon Pies because they contain undeclared partially hydrogenated soybean oil and wheat.
Galil Medical is recalling Visual-ICE Cryoablation Systems because gas regulators may fail, rendering the devices inoperable.
Stryker is recalling 159 Powered MOV Chairs due to potential compliance issues in product documentation and classification identified during a merger review.
Stryker Spine is recalling 40 units of Instructions For Use for TRIO+ Standard Post Screws because the front cover was incorrectly marked with a 'Sterile' logo.
Stryker is recalling 159 Powered MOV Chairs to address potential compliance issues regarding product documentation and classification identified during a corporate merger.
Stryker is recalling 159 Powered MOV Chairs to address potential compliance issues regarding product documentation and classification identified during a merger review.
Sunquest Information Systems is recalling Sunquest Laboratory SMART software versions 6.4.2 due to a defect that may display incorrect patient demographic data.
Spartan Central Kitchen is recalling 4oz sandwich spreads because the label failed to declare Yellow # 5 as an ingredient.
GE OEC Medical Systems is recalling 845 fluoroscopes because the Snubber Board does not meet IEC 60601-1 safety standards for voltage isolation.
VistaPharm is recalling Xactdose Phenytoin Oral Suspension because defective container lids allow moisture loss, potentially causing viscosity and assay failures.
Biomet U.K., Ltd. is recalling 119 Oxford Gap Gauge instruments because a drafting error resulted in misleading dimensions on the product drawings.
Beckman Coulter is recalling 41 DxH Slidemaker Stainer Floor Stands because missing vinyl caps expose sharp edges on drawer slides, posing a physical injury risk to operators.
Noven Pharmaceuticals is recalling 121,530 Daytrana patches because the release liner may be difficult to remove. The defect affects the patch's mechanical peel force.
Siemens is recalling ADVIA Centaur Syphilis Assay kits because they may interfere with Hepatitis B surface antigen testing, potentially affecting diagnostic accuracy.
Victus, Inc. is voluntarily recalling 1,535 tubes of Hipoglos Ointment in Florida because the product is misbranded.
Noven Pharmaceuticals is recalling 231,270 Daytrana patches because the release liner may be difficult to remove.
GE Healthcare is recalling 175 OEC 8800 Mobile Fluoroscopic X-ray Systems worldwide because they did not meet manufacturer specifications for linearity.
Prometheus Laboratories is recalling specific lots of Mercaptopurine Tablets, 50 mg, because they failed USP dissolution test requirements.
McKesson Medical Imaging Group is recalling Horizon Medical Imaging systems because reports may be saved with an incorrect final status.
Conformis Inc is recalling 1,427 iTotal CR Knee Replacement Systems to add a labeling addendum with detailed surgical instructions for poly insertion.
Morton Salt Co. is recalling specific lots of Sodium Chloride USP due to slightly out-of-specification bromide levels.
Sunquest Information Systems is recalling Encompass software versions 2.4 and later because specimen collection times display one hour late during Daylight Saving Time.
Stryker is recalling 159 Powered MOV Chairs due to potential compliance issues regarding product documentation and classification identified during a merger review.
Beckman Coulter is recalling Access Total T3 Reagent because test results may show a negative bias when specific sample diluents are used.
SJC is recalling 2012 Marque and McCoy-Miller ambulances because improperly torqued mounting bolts could cause the ambulance box to detach, increasing injury risk in a crash.
NBC Truck Equipment is recalling 2007-2011 trucks with Sure Power battery separators that may overheat, causing smoke or fire.
ShowHauler is recalling 2009-2011 Motorhomes, Toter Coaches, and Garage Coaches because Sure Power battery separators may overheat, causing smoke or fire.
Sherwin-Williams is recalling specific Krylon glaze and acrylic paints because the aerosol canisters can leak, posing a fire hazard if stored near ignition sources.
Heartland is recalling 2011-2013 Elkridge and Bighorn Silverado fifth wheels because an incorrectly connected propane line may cause an explosion.
Lippert Components is recalling 2011-2012 Extreme boat trailers equipped with specific Carlisle wheels that may not tighten to proper torque, posing a risk of wheel separation.
Eecycleworks is recalling about 400 'eebrake' model bicycle brakes because the bridge can crack, posing a fall hazard to riders.
Volvo is recalling 2013 S80 and XC70 vehicles because a software error prevents the tire pressure monitoring system from warning drivers of low tire pressure.
Sherwin-Williams is recalling specific cans of Dupli-Color Perfect Match automotive paint because the canisters can leak and pose a fire hazard.
Sherwin-Williams is recalling Tree House Studio Clear Acrylic Matte Coating because the aerosol canister can leak, posing a fire hazard if stored near ignition sources.
Calhome, Inc. is recalling specific motorcycle helmets that fail to meet federal impact and retention safety standards, increasing crash injury risk.
McClain Trailers is recalling 2011-2012 AT and ATT boat trailers because aluminum wheels may not tighten to proper torque, risking wheel separation.
IDM Group is recalling CareBears pacifiers because the nipples can separate from the base, posing a choking hazard to young children.
Zest Garden is recalling Wilson & Fisher White Cast Bistro Sets because the chairs can break during normal use, posing a fall hazard.
Mansfield Plumbing Products is recalling about 100 acrylic bathtubs, whirlpools, and air massage bathtubs because the grab bars can loosen and break, posing a fall hazard.
St Clair Foods is recalling 4/5 SYS Sliced Yellow Onions distributed by Sysco in Tennessee due to potential Listeria monocytogenes contamination.
Hannaford Bros. is recalling cold and hot Meatball Paninis because they contain meatballs recalled for potential Listeria monocytogenes.
Stryker is recalling Neptune 1 Silver Rover devices due to reports of serious tissue injury and a fatality, as well as a lack of FDA clearance.
Stryker is recalling Neptune waste management systems after reports of serious tissue injury and one fatality. The devices also lack FDA clearance.
Stryker is recalling Neptune 1 Gold Rover waste management systems due to reports of serious injury and a fatality associated with the Neptune 2 system.
Publix Super Markets is voluntarily recalling custom-made sub sandwiches containing onions sold in specific states due to potential Listeria monocytogenes contamination.
Stryker is recalling Neptune waste management system instructions due to reports of serious injury and one fatality from improper use.
St Clair Foods is recalling diced yellow onions distributed by Sysco in Tennessee due to potential Listeria monocytogenes contamination.
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Franck's Lab Inc. is recalling Depo-Testosterone injectable units because FDA sampling found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.
Philips Healthcare Inc. is recalling seven Essenta DR X-ray systems because the C-arm may fall. The recall covers units distributed in the US and several international countries.
Franck's Lab Inc. is recalling sterile ophthalmic solutions distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Compounding Lab is recalling 92 units of morphine sulfate injectable products due to a lack of assurance of sterility.
Franck's Lab Inc. is recalling sterile tobramycin drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Compounding Lab is recalling sterile Amikacin drugs because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling specific sterile intrathecal drug mixtures because FDA sampling found microorganisms in the production clean room.
Franck's Lab Inc. is recalling sterile injectable drugs containing methylprednisolone and lidocaine because environmental sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile Thiotepa injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile methylcobalamin injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile bupivacaine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Lab Inc. is recalling 19 units of Ranibizumab injectable because FDA testing found microorganisms in the clean room where the sterile drugs were prepared.
Franck's Lab Inc. is recalling Strontium 1 mg/mL Injectable due to microorganisms found in the clean room where sterile products were prepared.
Franck's Lab Inc. is recalling sterile Papaverine HCL injectable vials because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Icrest International LLC is recalling frozen oyster meat from Korea because it was prepared under insanitary conditions that may have rendered it injurious to health.
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile cyanocobalamin (Vitamin B12) injectables because FDA sampling found microorganisms and fungal growth in the clean room where the products were prepared.
Franck's Lab Inc. is recalling specific sterile injectable drugs because FDA sampling found microorganisms and fungal growth in the production clean room.
Franck's Lab Inc. is recalling sterile Thiamine HCL injectable products because FDA sampling found microorganisms and fungal growth in the preparation clean room.
Franck's Lab Inc. is recalling sterile midazolam injectables distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile ophthalmic solutions distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile DMPS injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Compounding Lab is recalling sterile triamcinolone acetonide drugs distributed between November 2011 and May 2012 due to the presence of microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling Folic Acid 10mg/mL Injectable because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.
Franck's Lab Inc. is recalling sterile injectable drugs and ophthalmic products distributed between November 2011 and May 2012 because FDA testing found microorganisms in the production clean room.
Franck's Lab Inc. is recalling sterile ophthalmic drugs distributed between November 2011 and May 2012 because environmental sampling found microorganisms in the clean room.
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Franck's Lab Inc. is recalling Acetazolamide injectable vials because FDA sampling found microorganisms in the clean room where they were prepared.
Franck's Lab Inc. is recalling 14 units of sterile Fluorouracil products due to microbial contamination found in the clean room.
Franck's Lab Inc. is recalling two units of Budesonide nasal irrigation solution because FDA testing found microorganisms in the production clean room.
Franck's Lab Inc. is recalling sterile ophthalmic solutions because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Franck's Compounding Lab is recalling 110 units of QUADMIX injectable drugs because FDA testing found microorganisms and fungal growth in the facility's clean room.
Franck's Lab Inc. is recalling sterile DMSO/Heparin/Methylprednisolone solution because FDA sampling found microorganisms and fungal growth in the clean room where the products were prepared.
Franck's Lab Inc. is recalling Humulin-R Insulin vials distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Franck's Lab Inc. is recalling sterile human drugs, including Theracys, because FDA testing found microorganisms and fungal growth in the clean room where the products were prepared.
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