Archive
607 recalls were announced in September 2012.
Of the 607 recalls this month scored against our rubric, 22% are Critical, 31% are Severe.
Which agencies issued them
Hospira Inc. is recalling Paclitaxel Injection vials because visible particles are embedded in the glass at the neck. The particles may dislodge into the solution.
Instrumentation Laboratory is recalling ACL TOP analyzers because they may report abnormal fibrinogen levels as normal or vice versa, potentially affecting clinical decisions.
Tedan Surgical Innovations is voluntarily recalling sterile distraction and XL screws because mechanical packaging failures may compromise sterility.
Biomet is recalling 62 units of the JuggerKnot 2.9mm In-Guide Punch because the knob may unfasten and slide down the shaft during use.
Asahi Kasei is recalling 55,632 REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.
Asahi Kasei is recalling 30,408 REXEED hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.
Elekta is recalling 110 Precise Digital Accelerators because a loose joint between the drive gear and gantry base drive wheel can lead to fatigue failure of securing bolts.
Asahi Kasei is recalling REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.
Dukal Corp. is recalling ZEE Antiseptic Wipes due to contamination with Burkholderia cepacia. The affected products were distributed nationwide.
Vascular Solutions, Inc. is recalling Guardian II Hemostasis Valves because some pouches are missing a seal, posing a risk of product contamination.
Philips Medical Systems is recalling 328 MX 16-slice CT Scanner Systems because a bolt may fail, causing the oil accumulator to detach from the tube housing assembly.
Atico International USA is recalling Roundy's Rich Fields Butter Cookies due to the presence of Toxigenic Bacillus cereus found in an FDA sample.
Integra LifeSciences is recalling CRW Precision Arc and HRAIM Head Ring Assemblies because a T-handle screw may prevent proper seating of the arc system.
Instrumentation Laboratory is recalling ACL TOP 700 analyzers because they may report abnormal fibrinogen levels as normal or low levels as high.
Smith & Nephew is recalling 70 modular hip neck components because the taper is undersized due to manufacturing errors.
San Francisco Herb & Natural Food Company is recalling Organic Yerba Mate after inspectors found a pervasive mouse infestation in the facility.
Instrumentation Laboratory is recalling ACL TOP 500 CTS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.
San Francisco Herb & Natural Food Company is recalling Peppermint Leaf Organic C/S because inspectors found a pervasive mouse infestation in the facility.
Instrumentation Laboratory is recalling ACL TOP 700 CTS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.
Big Lots is recalling Wilson & Fisher garden swings because the wooden bench seats can break, posing a fall hazard.
Varian Medical Systems is recalling 221 linear accelerators worldwide because incorrect metal alloy in X-jaw carriers may cause cracking and undetected under-dosing.
San Francisco Herb & Natural Food Company is recalling Marigold Petals Whole due to a pervasive mouse infestation found in the facility by CA inspectors.
San Francisco Herb & Natural Food Company is recalling Olive Leaf Organic Whole because inspectors found a pervasive mouse infestation in the facility.
Hospira is recalling 210 vials of Cytarabine Injection because visible particles embedded in the glass neck may dislodge into the solution.
Zoe Medical Incorporated is recalling 35 Spacelabs Ultraview DM3 Monitors because they fail to power up, causing equipment alarms.
San Francisco Herb & Natural Food Company is recalling Thyme Leaf C/S because inspectors found a pervasive mouse infestation in the facility.
Kimberly-Clark is recalling MIC PEG Kits - Pull Type because the placement guidewire is too large to pass through the introducer needle.
The FDA is recalling HALO Flex Energy Generators because they may fail to enter standby mode upon startup, rendering them unusable for patient care.
Bio-Rad Laboratories is recalling MONOLISA Anti-HBs EIA kits because light exposure to the Conjugate Diluent may cause false positive or grey zone results.
US Endoscopy is recalling 393 Infinity sampling devices because the cytology brush may be difficult to deploy through the catheter.
Steris Corporation is recalling Verify Bowie-Dick Test Cards because they may produce false fail results, potentially indicating sterilizer issues when performance is actually acceptable.
Friendly Ice Cream Corp. is recalling 59,052 cartons of Sundae Nut Football Limited Edition ice cream due to the presence of foreign material.
Haag-Streit USA Inc recalled 64 Octopus 101 Perimeters because of a possible deviation in stimulus luminance. The devices are used to determine the extent of a patient's peripheral visual field.
Integra Life Sciences is recalling 2,389 units of 2.7mm Drilling Guides because they may break during surgical use, potentially increasing procedure time.
DePuy Orthopaedics is voluntarily recalling four lots of S-ROM Total Hip System Poly Liners because the carton labels contain an incorrect color code series designation.
Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to packaging mislabeling where product sizes do not match package labels.
Kimberly-Clark is recalling 277 units of MIC Safety PEG Kits because the placement guidewire is too large to pass through the introducer needle.
R&S Mexican Food Products is recalling Tomato/Basil Pressed Tortillas because they contain undeclared FD&C Yellow #6. The product was distributed to four accounts in Arizona.
Tunnel Farms is recalling seedless watermelons labeled 'IT'S WATERMELON TIME!' because unapproved pesticide residue was detected.
Friendly Ice Cream Corp. is recalling 19,860 cartons of Fudge Nut Brownie Sundae Extreme due to the presence of foreign material.
Friendly Ice Cream Corp. is recalling 86,136 cups of Nutty Caramel Crunch Sundae due to the presence of foreign material.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Prolactin Assay and Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.
Sekisui Diagnostics is recalling Spectrolyse PAI-1 kits because they produce lower than expected absorbance values, which may require more frequent sample dilutions.
Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to size mislabeling on the packaging.
ZOLL Medical Corporation is recalling 11 Zoll X Series Defibrillator/Pacemaker/Monitor units because they were shipped with incorrect software.
Sandoz Incorporated is recalling specific lots of Pramipexole Dihydrochloride Tablets because stability testing revealed an out-of-specification impurity.
BD Biosciences is recalling 96 kits of BD FACS 7-color Setup Beads because the included CD contained the incorrect version.
Amsino Medical USA is recalling one lot of 0.9% Sodium Chloride Flush syringes that may be mislabeled as 10 mL instead of 3 mL.
Sandoz Incorporated is recalling Pramipexole Dihydrochloride Tablets, 0.25 mg, because an out-of-specification result for a known impurity occurred during stability testing.
Apace KY LLC is recalling 81,516 bottles of Enalapril Maleate 5mg tablets because some labels have incomplete NDC numbers and missing strength information.
Kimberly-Clark is recalling 32 cases of sterile surgical gowns that were not intended for commercial distribution to end users.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur FSH Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.
Amsino Medical USA is recalling one lot of 0.9% Sodium Chloride Flush syringes that may be mislabeled as 10 mL instead of 3 mL.
Philips is recalling 93 Brilliance CT 16 systems because a software defect may cause the system to fail to log out, requiring a forced restart.
Impact Instrumentation, Inc. is recalling two Model 324JL On-Board Suction Systems due to a shipment mix-up. The devices were distributed nationwide, including in Florida and Ohio.
GMP Laboratories of America Inc is recalling 1,027 boxes of 'Rescue Me' herbal supplements because some packets contain fewer capsules than labeled.
Heartland is recalling 2012-2013 Bighorn Silverado Fifth Wheel Travel trailers because a liquid propane hose may contact tires, causing damage that could lead to a leak and fire.
Specialized Bicycle Components is recalling approximately 12,000 2008 and 2009 Globe model bicycles because the front fork can break, posing fall and injury hazards to riders.
Vehicle Production Group is recalling 2011-2012 MV-1 vehicles with CNG engines because the pressure relief plug may be incorrectly assembled, posing a fire risk.
Thor Industries is recalling specific Eldorado motorhomes due to a potential turbocharger failure that could cause engine damage, oil leaks, or fires.
Newmar is recalling 278 Dutch Star and Dutch Aire motorhomes because front brake chambers may contact the suspension, causing brakes to drag and potentially leading to a crash.
New Flyer is recalling 163 transit buses due to a turbocharger defect that may cause engine damage, oil leaks, smoke, or fire.
Vermeer is recalling three HG6000TX horizontal grinder trailers because a defective kingpin may fail, causing the trailer to separate from the towing vehicle.
Nissan is recalling 2012 Frontier, Pathfinder, and Xterra vehicles because front wheel hubs may not meet hardness specifications, potentially leading to cracking and vehicle crashes.
Navistar is recalling specific International trucks because an air leak in the parking brake chamber may prevent the brake from fully releasing, increasing crash risk.
Hayneedle is recalling Shorea Wooden Arc Hammock Stands because the wood layers can separate, causing the stand to break and posing a fall hazard.
ThyssenKrupp Access Manufacturing is recalling LEV II, Volant, and Rise residential elevators because the door can open without the car present, posing a fall risk.
Garden-Fresh Foods is recalling Southwestern Pasta Salad because it contains onions potentially contaminated with Listeria monocytogenes.
Garden-Fresh Foods is recalling Deviled Egg Salad due to potential Listeria monocytogenes contamination from onions supplied by Gills Onions.
Garden-Fresh Foods is recalling Creamy Cole Slaw Dressing because it contains onions potentially contaminated with Listeria monocytogenes.
Missa Bay, LLC is recalling Wegmans Apples, Celery, Raisins, & Peanut Butter due to Listeria monocytogenes contamination. The product was distributed in 35 states and DC.
Garden-Fresh Foods is recalling 5 lb. packages of Black Bean Couscous due to potential Listeria monocytogenes contamination from recalled onions.
Garden-Fresh Foods is recalling Knowlan's Club Salad Base because it contains onions recalled for potential Listeria monocytogenes contamination.
Missa Bay, LLC is recalling Wawa Chicken Salad Snacks because they are contaminated with Listeria monocytogenes. The recall covers 264,662 cases and 296,224 individually distributed units.
Missa Bay, LLC is recalling McDonald's M fruit & walnut snack with vanilla lowfat yogurt due to Listeria monocytogenes contamination.
Garden-Fresh Foods is recalling DF Special Recipe Macaroni Salad due to potential Listeria monocytogenes contamination from onions.
Missa Bay, LLC is recalling Ready Pac Ready Snax Apples & Cheese with Caramel Dip Snack Pacs because they are contaminated with Listeria monocytogenes.
Garden-Fresh Foods is recalling Finest Traditions XTRA Creamy Cole Slaw because it contains onions potentially contaminated with Listeria monocytogenes.
Missa Bay, LLC is recalling Crown Program BK Fresh Apple Slices contaminated with Listeria monocytogenes. The recall covers 264,662 cases and 296,224 units distributed across 36 states and DC.
Whole Foods Market in Florida is recalling prepared foods and one seafood item that may contain raw yellow onions processed by Gill Onions, LLC, due to possible Listeria monocytogenes contamination.
Garden-Fresh Foods is recalling Acme Homestyle Cole Slaw because it contains onions potentially contaminated with Listeria monocytogenes.
Garden-Fresh Foods is recalling Family Style Macaroni Salad because it contains onions potentially contaminated with Listeria monocytogenes.
Missa Bay, LLC is recalling Safeway Farms Complete Apple, Blue Cheese & Pecan salad due to Listeria monocytogenes contamination.
Garden-Fresh Foods is recalling specific lots of potato salad due to potential Listeria monocytogenes contamination from onions.
Garden-Fresh Foods is recalling Country Style Potato Salad due to potential Listeria monocytogenes contamination from onions.
Garden-Fresh Foods is recalling Spoon River Potato Salad due to potential Listeria monocytogenes contamination in onions.
Missa Bay, LLC is recalling Ready Pac super fruit blend due to Listeria monocytogenes contamination. Consumers should check their pantries and discard or return the product.
Missa Bay, LLC is recalling Wawa Protein Power Packs due to Listeria monocytogenes contamination. Consumers should discard the product.
Missa Bay, LLC is recalling Wawa apple caramel dippers because they are contaminated with Listeria monocytogenes. The recall covers units distributed in 35 states and DC.
Garden-Fresh Foods is recalling specific Amish Potato Salads because they contain onions potentially contaminated with Listeria monocytogenes.
Whole Foods Market in Florida is recalling prepared foods and seafood items that may contain raw yellow onions from Gill Onions, LLC, due to possible Listeria monocytogenes contamination.
Garden-Fresh Foods is recalling specific lots of Fresh Salsa due to potential Listeria monocytogenes contamination from onions.
Missa Bay, LLC is recalling Hannaford Apple, Granola, & Yogurt Snack Pacs due to Listeria monocytogenes contamination.
Garden-Fresh Foods is recalling Creamy Cole Slaw products due to potential Listeria monocytogenes contamination from onions.
Whole Foods Market in Florida is recalling fresh prepared foods and seafood items that may contain raw yellow onions from Gill Onions, LLC, due to possible Listeria monocytogenes contamination.
Garden-Fresh Foods is recalling Archer Farms Four Bean Salad due to potential Listeria monocytogenes contamination in onions.
Garden-Fresh Foods is recalling Finest Traditions Pea & Cheese Pasta Salad due to potential Listeria monocytogenes contamination in onions.
Garden-Fresh Foods is recalling specific Garden-Fresh and Weis red potato salads due to potential Listeria monocytogenes contamination from onions.
Missa Bay, LLC is recalling Ready Pac Sweet Sunshine Platters because they are contaminated with Listeria monocytogenes. Consumers should stop using the product.
Garden-Fresh Foods is recalling specific lots of Taco Pasta Salad because they contain onions potentially contaminated with Listeria monocytogenes.
Looking for a different month? Back to 2012.