Archive
675 recalls were announced in September 2014.
Of the 675 recalls this month scored against our rubric, 9% are Critical, 22% are Severe.
Which agencies issued them
Life Force of Tampa, LLC is recalling 10 Life Force Chambers because the product is marketed as a medical device without FDA premarket approval.
CT Concerns, Inc. is voluntarily recalling fresh wild tuna and farmed Atlantic salmon due to potential Listeria monocytogenes contamination found in environmental swabs.
Marjon Specialty Foods is recalling Marjon Alfalfa Sprouts because environmental samples in the production area tested positive for Listeria.
The FDA is recalling GONG XIFACAI gift chocolates because testing revealed undeclared peanuts and milk in the product.
Durrset Amigos, Ltd. is recalling H-E-B Chipotle Con Queso because a supplier used wheat instead of whey in the cheese premix, creating an undeclared wheat allergen.
Wright Medical Technology is recalling 18 units of CLAW II Straight Plate OrthoLoc 3DSi orthopedic plates because they were manufactured from an incorrect raw material.
Marjon Specialty Foods is recalling Marjon Spicy Sprouts because environmental samples found Listeria in the production area.
Illumina Inc is recalling 35 units of Illumina Worklist Manager software v1.0.15 because it fails to perform as intended.
GE Healthcare is recalling 748 CARESCAPE respiratory modules and Airway Gas Options due to a potential O2 sensor component failure.
Radiometer America Inc. is voluntarily recalling RADIANCE software versions 2.4X, 2.5X, and 2.6X. The recall is classified as Class II by the FDA.
Siemens is recalling 192 Luminos dRF, Ysio, and Uroskop Omnia systems because a software malfunction may cause longer radiation exposure than required.
Pioneer Surgical Technology is recalling nine Streamline MIS Spinal Fixation System Fixed Rod Holders because they failed to lock onto the spinal rod.
Durrset Amigos, Ltd. is recalling Hill Country Fare Salsa Con Queso Sauce due to undeclared wheat, a common allergen.
Wright Medical Technology is recalling 497 CLAW II 2 Hole Plate OrthoLoc 3DSi orthopedic plates because they were manufactured from an incorrect raw material.
Ab Sciex is recalling six API 3200MD LC/MS/MS systems because the MultiQuant 3.0 software may provide incorrect data for patient diagnosis.
Concentric Medical Inc is recalling nine Merci Retriever devices shipped past their expiration date. The devices were labeled with the correct expiration date but distributed to US customers after that date.
CooperSurgical is recalling 1,400 H/S Catheters intended for hysterosonography because some pouches were unsealed.
Wright Medical Technology is recalling 1,127 CLAW II 2 Hole Plate Ortholoc 3DSi units because they were manufactured from an incorrect raw material.
Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps because a packaging defect may compromise sterility. The recall affects 24,910 units distributed in four states.
Medtronic is recalling two units of the Hancock Apical Left Ventricle Connector because the company has decided to discontinue production and distribution of this low-volume product.
Primus Medical LLC is recalling specific Transcend and Bariatric mattresses because the top cover is delaminating. The recall affects 1,557 units distributed in the US and Canada.
Integra York PA, Inc. is recalling 84 container lids that were distributed without FDA clearance.
Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.
Becton Dickinson is recalling 585,048 BD MAX MRSA Assay tests because some samples yielded false positive results during CAP surveys.
Biomet 3i is recalling 6 units of Bellatek Encode Healing Abutments because the labels have incorrect color coding, though the identifiers are correct.
ChiroNutraceutical LLC is recalling Chirothin dietary supplement bottles because the product contains unapproved human chorionic gonadotropin (hCG) and was marketed without an approved NDA or ANDA.
Grace Foods (USA) Inc is recalling Grace Classic Coconut Milk cans due to a label misprint that incorrectly states no gums, thickeners, or stabilizers were added.
IKEA is recalling GUNGGUNG children's swings because suspension fittings can break, causing children to fall. Consumers should remove the swing and return it for a refund.
RevZilla is recalling specific LaZer motorcycle helmets because they may lack correct size labels, potentially compromising fit and safety.
Nissan is recalling 2013 Altima vehicles because hood latch interference may cause the hood to open while driving, increasing crash risk.
Jerky By Art is recalling Claude's Beef Jerky with Red Chile because it was produced without USDA inspection and contains undeclared wheat and anchovies.
Mitsubishi is recalling certain 2011 Outlander Sport vehicles because a cracked brake booster switch sleeve may prevent the brake pedal from returning, increasing crash risk.
Lion Bus is recalling 2013-2014 360 school buses because improperly applied adhesive on ceiling panels may fail in a crash, increasing injury risk.
Mitsubishi is recalling 2008-2011 Lancer, Lancer Evolution, and Outlander models because the engine drive belt may detach, causing the engine to stall and increasing crash risk.
Interbay Food Company is recalling approximately 4,820 pounds of pork Banger-style sausage because the products contain milk, a known allergen, which is not declared on the label.
Mitsubishi is recalling 2007-2009 Outlander vehicles because the brake light switch may malfunction, preventing brake lights from illuminating and increasing crash risk.
Halcore is recalling 29 model year 2014 Horton ambulances equipped with Liquid Spring aftermarket suspension kits because the fluid tank mounting bracket may fail.
Jayco is recalling 2015 Jay Flight 19RD trailers because the roof ladder may be installed on the wrong side without proper support, increasing injury risk.
Volvo is recalling 3,175 model year 2014-2015 VAH, VNL, and VNM trucks because disc brake caliper bolts may not be tightened to specification, increasing crash risk.
Arctic Cat is recalling about 5,600 Wildcat Trail and Wildcat Trail XT side-by-side utility vehicles because oil can leak from the oil cooler lines, posing a fire hazard.
Mack Trucks is recalling 2015 Granite trucks because a fuel filter defect may cause the engine to stall without warning, increasing the risk of a crash.
Kidde is recalling about 1.3 million hard-wired smoke and combination smoke/CO alarms because they may fail to alert users during a power outage. No injuries have been reported.
Toyota is recalling 2014 Tundra CrewMax and Double Cab vehicles because a B-pillar trim misinstallation may prevent side air bags from deploying properly in a crash.
Volvo is recalling 2015 VNL and VNX trucks because a software error may cause the engine to stall while driving, increasing crash risk.
Mack Trucks is recalling 2015 CHU, CXU, and GU trucks because seat belt bolts may not be torqued correctly, risking detachment in a crash.
Customed, Inc. is recalling 1,041 units of EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling EO sterilized surgical gowns because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed is recalling specific lots of HIP PACK I surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling Neuro Spine Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
GoMacro is recalling specific lots of almond butter and sunflower butter bars due to potential Salmonella contamination.
Customed, Inc. is recalling C-Section surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 1,536 units of Angiodrape Packs due to potential packaging integrity issues that could compromise sterility and risk patient injury.
Customed, Inc. is recalling 273 units of arthroscopy packs across 11 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling EENT surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 74 units of Shoulder Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling Endovascular Packs (code 900-2715) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 12 lots of Endoveneous Custom Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling specific lots of EO-sterilized surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling Fanfold Drapes due to potential packaging integrity issues that could compromise sterility and risk patient injury.
Customed, Inc. is recalling 112 units of Extremity Arm Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Oasis Brands is recalling Lacteos Santa Martha Fresh Curd because a state sample tested positive for Listeria monocytogenes.
Customed, Inc. is recalling Major Lap Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 114 units of Shoulder Packs (Code 900-2616) because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.
Customed, Inc. is recalling 720 units of Premium Ophthalmic Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling vaginal procedure packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 3,448 units of Labor and Delivery Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling Central Line Full Body Drapes because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 30 lots of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Puratos Chocolate USA is recalling 22,000 lbs of Dark Organic 1M Chip chocolate due to a reported allergic reaction to milk protein.
Customed, Inc. is recalling O.B. Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 39 lots of arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 30 lots of EO sterilized laparoscopy convenience packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.
Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling plastic surgery packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 2,950 units of Dressing Change packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Apotex Inc. is recalling PAXIL (Paroxetine HCL) Oral Suspension because it was manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Apotex Inc. is recalling specific lots of PAXIL (Paroxetine HCL) 20 mg tablets because they were manufactured with active pharmaceutical ingredients contaminated with residual materials and solvents.
Apotex Inc. is recalling PAXIL CR tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Customed, Inc. is recalling specific lots of Liposuction Pack MRT due to potential packaging integrity issues that could compromise sterility.
Customed, Inc. is recalling specific lots of laparotomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Elekta is recalling FOCAL Sim Workstation software versions 4.70.00 and 4.80.00 because exported arc plans may not match approved treatment plans.
Super Organic Foods, Inc. is recalling Sunburst Organic Raw Carob Powder in 1-pound and 5-pound bags due to potential Salmonella contamination from raw materials.
Omix Ada is recalling aftermarket floor mats for Chevrolet and GMC trucks because they may move forward and interfere with the accelerator pedal, increasing crash risk.
Customed, Inc. is recalling 29 lots of Cysto TUR Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
River Canyon Retreat is recalling Organic Carob Powder due to Salmonella contamination. The product was distributed in the US and Canada.
Apotex Inc. is recalling Paroxetine Hydrochloride Controlled-Release Tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Customed, Inc. is recalling 93 units of Laparotomy Packs (900-2516) because packaging integrity may be compromised, risking product contamination or loss of sterility.
Apotex Inc. is recalling PAXIL (Paroxetine HCL) 10 mg tablets because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.
Gillig is recalling 90 model year 2014 Low Floor transit buses because crossed air brake supply lines may cause brake failure, increasing crash risk.
Crown Food Distribution is recalling Golden Natural Mix Party due to undeclared sulfites. The product was distributed in New Jersey and New York.
Apotex Inc. is recalling PAXIL (Paroxetine HCL) 40 mg tablets due to contamination with residual materials and solvents.
Customed is recalling 402 units of Orthopedic Pack Basic (Code 900-2830) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling Extremity Packs (code 900-2615) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 36 units of Hip Orthopedic Packs because packaging integrity may be compromised, risking patient injury from contamination or loss of sterility.
Customed, Inc. is recalling carpal tunnel surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 440 units of Urology Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 2,233 units of EO sterilized surgical laparotomy packs because packaging integrity may be compromised, risking product contamination or loss of sterility.
Customed, Inc. is recalling Chole Cystectomy All Endo System kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Customed, Inc. is recalling 96 units of Face Pack Aesthetic Surgery kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Sunfood Superfoods is recalling Organic Carob Powder because it may be contaminated with Salmonella. The recall affects 1 lb., 20 lb., and 55 lb. bags.
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