Archive
451 recalls were announced in December 2018.
Of the 451 recalls this month scored against our rubric, 3% are Critical, 30% are Severe.
Which agencies issued them
Mercedes-Benz is recalling 2019 C300 and AMG C43 vehicles because a software defect may prevent the electronic parking brake from disengaging.
Mylan is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity NDEA in the active ingredient.
GE Healthcare is recalling 33,065 PROCARE B40 patient monitors because network configuration issues may cause the devices to restart unexpectedly.
Mercedes-Benz is recalling 2018-2019 GLC63 and GLC63S vehicles because the frontal air bag may deploy late for unbelted passengers, increasing injury risk.
Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging due to broken seals that compromise sterility and increase infection risk.
Howmedica Osteonics Corp. is recalling 28,461 Tritanium Posterior Lumbar cage implants because of reports of fractures occurring during or after surgery.
Seagrave is recalling 2017-2018 Capital and Marauder II emergency vehicles because Whelen accessory brake lights may falsely illuminate, increasing crash risk.
Neotract is recalling UroLift System devices because the capsular tab may fail to deploy, potentially delaying or preventing treatment completion.
GE Healthcare is recalling 28,004 PROCARE B20 patient monitors because network configuration issues may cause the devices to restart unexpectedly.
CIVCO Medical Instruments is recalling 738 boxes of Needle Guide Brackets because they may puncture the sterile cover during assembly.
Heartware, Inc. is recalling 2,031 HVAD System Battery Charger units because they were manufactured with incorrect inductors. The recall covers units distributed in the US and multiple international countries.
BMW is recalling 2019 X5 xDrive40i and xDrive50i vehicles because the sun visors may lack required air bag warning labels, increasing injury risk in crashes.
GNC is recalling Women's Iron Complete supplements because the blister packaging is not child-resistant, posing a risk of poisoning to children.
Gemini Food Corporation is recalling Imperial Taste Fried Red Onion because an investigation found undeclared wheat in the ingredients.
Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging because broken seals may compromise sterility, increasing infection risk.
Mercedes-Benz is recalling 2018 S-Class and AMG S63 vehicles because an incorrect steering boot installation may keep the Active Steering Assist system engaged while the driver's hands are off the wheel.
Gemini Food Corporation is recalling Imperial Taste Fried Garlic due to undeclared wheat. The product is distributed in multiple states.
Mercedes-Benz is recalling 2018-2019 S-Class vehicles because the hands-off detection system may fail, keeping steering assist active without driver input.
Philips is recalling 1,880 HeartStart MRx lithium-ion batteries because a defective component may prevent the battery from charging or delivering power to the monitor/defibrillator.
GE Healthcare is recalling 6,864 B40i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.
GE Healthcare is recalling 6,458 B20i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.
Mercedes-Benz is recalling 2019 CLS 450 and AMG CLS53 vehicles because unsealed headlight adjustment screws may cause improper alignment, increasing crash risk.
Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging because broken seals may compromise sterility, increasing infection risk.
4Patriots, LLC is recalling Chicken a la King pouches because milk is not declared on the label. The product was sold nationwide in emergency kits.
Feast Mode Blending & Filling is recalling 5,000 units of Garlic Beer Seasoning because the product is mislabeled as 'Gluten Free'.
GE Healthcare is recalling 5,516 B105/125 patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.
Jackie's Cookie Connection is recalling 9,720 units of Jackie's Cookie Babies Classic Chocolate Chip cookies due to potential metal fragments.
CIVCO Medical Instruments is recalling 49 boxes of Needle Guide Brackets because some units lack required product labeling.
Dr. Reddy's Laboratories is recalling specific lots of Clopidogrel Bisulfate 300 mg tablets because they failed dissolution specifications during stability testing.
CAO Group, Inc. is recalling fas.TRACT Coagulative Hemostatic Gel kits due to current Good Manufacturing Practice (cGMP) violations identified during a recent inspection.
CAO Group, Inc. is recalling FastStat Topical Hemostat Introductory Kits because cGMP violations were noted during the firm's most recent inspection.
CIVCO Medical Instruments is recalling 115 boxes of SonoSite FUJIFILM Needle Guide Brackets due to missing product labeling. The recall covers units distributed in the US and 40 foreign countries.
Helena Laboratories is recalling Cascade Abrazo c-ACT-LR test cards due to waveform variations that may result in inaccurate clotting time measurements.
Philips is recalling IntelliVue MX40 patient monitors because the speaker volume may be diminished or inaudible at altitudes above 4,500 feet.
CIVCO Medical Instruments is recalling 66 boxes of Needle Guide Starter Kits because some brackets lack required product labeling. The recall covers units distributed globally.
Zimmer Biomet is recalling specific lots of orthopedic stems because they may be mislabeled, potentially extending surgery time by up to 30 minutes.
Tosoh Bioscience is recalling 258 AIA-900 Automated Immunoassay Analyzers because internal harnesses may wear prematurely, causing the device to stop functioning and delaying patient test results.
CIVCO Medical Instruments is recalling 234 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.
CAO Group, Inc. is recalling BeeGentle Honey Flavored Topical Anesthetic because of current Good Manufacturing Practice (cGMP) violations found during a recent FDA inspection.
The Gatorade Puerto Rico Co is recalling Gatorade Combo multipacks due to mold contamination. Consumers should stop using the affected products.
Tosoh Bioscience is recalling AIA-900 and AIA-2000 analyzers due to a potential incubator slippage issue that may cause system errors and delays in patient test results.
The Gatorade Puerto Rico Co is recalling Gatorade Melon beverages due to mold contamination. Consumers should stop using the product.
CIVCO Medical Instruments is recalling 468 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.
CIVCO Medical Instruments is recalling 3 boxes of Needle Guide Brackets because some units lack required product labeling. The recall covers specific lot numbers and inventory without labels.
COVIDIEN LLC is voluntarily recalling 1,522 Salem Sump Dual Lumen Stomach Tubes because one lot of 10 Fr tubes was incorrectly packaged in 16 Fr pouches.
CIVCO Medical Instruments is recalling 613 boxes of Needle Guide Starter Kits due to missing product labeling on reusable brackets.
CIVCO Medical Instruments is recalling 20 boxes of Needle Guide Starter Kits due to missing product labeling. The voluntary recall covers units distributed in the US and 40 foreign countries.
The Binding Site Group is recalling 60 units of Human IgM Kits due to challenges in validating the calibration curve, indicated by control values outside specified ranges.
CIVCO Medical Instruments is recalling 135 boxes of Sales Demo Kits because some inventory brackets no longer have product labeling.
Angiodynamics Inc. is recalling specific lots of Xcela Power Injectable PICCs because they are labeled with expiration dates that extend shelf life beyond validated testing.
CAO Group, Inc. is recalling SHEER DesenZ Desensitizing Treatment because cGMP violations were noted during the firm's most recent inspection.
The Gatorade Puerto Rico Co is recalling Gatorade Frost Glacier Freeze 600 mL bottles due to mold contamination. The recall covers 684 cases distributed to domestic consignees.
The Gatorade Puerto Rico Co is recalling 200 cases of Gatorade Cool Blue due to mold contamination. Consumers should discard the product.
QuVa Pharma is recalling 168 bags of Norepinephrine Injection compounded in 5% Dextrose instead of 0.9% Sodium Chloride. The product was distributed in California.
Tosoh Bioscience is recalling AIA-2000 and AIA-900 analyzers because a timing belt issue can cause incubator slippage, leading to system errors and delays in patient test results.
CIVCO Medical Instruments is recalling 257 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.
The Gatorade Puerto Rico Co is recalling specific lots of Gatorade Fruit Punch 600 mL bottles due to mold contamination.
The Gatorade Puerto Rico Co is recalling specific lots of Gatorade Lemon Lime due to mold contamination. Consumers should check lot numbers and expiration dates.
The Gatorade Puerto Rico Co is recalling specific lots of Gatorade Grape due to mold contamination. Consumers should discard the affected product.
LGM Pharma LLC is recalling 1,307 kg of Thyroid Powder, USP, because the product has inconsistent levels of active ingredients levothyroxine and liothyronine.
Zimmer Biomet is recalling specific lots of the Orthopedic Salvage System Porous Stem because the Mini Humeral Stem may be mislabeled as the Bowed IM Stem.
CIVCO Medical Instruments is recalling 73 boxes of Biopsy Brackets because some units lack required product labeling.
CIVCO Medical Instruments is recalling 297 boxes of SonoSite Needle Guide Brackets because some units lack required product labeling.
Angiodynamics Inc. is recalling specific lots of BioFlo PICCs labeled with incorrect expiration dates that extend shelf life beyond validated testing.
The Gatorade Puerto Rico Co is recalling specific lots of Gatorade Orange 600 mL bottles due to mold contamination.
Tosoh Bioscience is recalling Hemoglobin A1c Control material due to potential degradation that may cause testing delays.
Russ Davis Wholesale is recalling ready-to-eat chicken Caesar wraps because they contain eggs, a known allergen, that is not declared on the label.
Ford is recalling 410,289 F-Series trucks because water in the block heater cable can cause corrosion and a fire.
Eldorado is recalling 2017-2018 Arrivo, Passport, and E-Z Rider Max BRT buses because back seat cushions may not stay locked in place during a crash.
The Children's Place is recalling about 14,900 infant snowsuits because metal snaps can detach, posing a choking hazard to young children.
TerraTrike is recalling about 450 Rambler E.V.O. adult tricycles because the torque sensor can activate unexpectedly, causing the trike to power forward and posing crash and injury hazards.
TAP Worldwide is recalling Poison Spyder Customs-brand Tire Carriers that may lack required brake lights or disable rear cameras, increasing crash risk.
Triple E is recalling 2019 Serenity recreational vehicles because a metal cable may contact the battery terminal, creating a fire hazard.
Volkswagen is recalling 2018 Audi A5 Sportback vehicles because front suspension fasteners may not be sufficiently tightened, which could cause a front wheel to become loose.
Heartland is recalling 2019 Milestone trailers because a propane hose may be improperly secured, posing a fire risk if it contacts the tire.
Blue Bird is recalling 2017-2019 Vision school buses with specific Cummins engines because a slipping air compressor belt may cause the parking brake to apply while driving, increasing crash risk.
Mannarich Food, Inc. is recalling approximately 145,245 pounds of Siluriformes fish products that were imported from Malaysia without U.S. inspection.
Autocar is recalling 2019 Xpeditor vehicles because universal joint strap bolts may not be properly tightened, which could cause the drive shaft to detach and increase crash risk.
Hyundai is recalling 2018 Elantra GT vehicles because the panoramic sunroof motor may be incorrectly programmed, preventing it from detecting obstacles while closing.
TAP Worldwide is recalling Poison Spyder Tire Carrier Delete Plates because they may interfere with brake lights and rear visibility systems, increasing crash risk.
Lifeworks is recalling specific Armor All heated seat cushions and blankets sold at Meijer because they may overheat and melt, posing a fire and injury risk.
Toyota is recalling 2018-2019 Tacoma vehicles because improper machining of the brake master cylinder may damage internal seals, potentially reducing brake performance and increasing crash risk.
Toyota is recalling 2008-2019 Land Cruiser and Lexus LX 570 vehicles because a broken wire harness may deactivate front passenger air bags, increasing injury risk in crashes.
Raj Imports is recalling about 300 women's silk scarves because they fail to meet federal flammability standards, posing a risk of burn injuries.
Frazer is recalling 2017-2018 Type 1 and Type 3 ambulances and Mobile Stroke Units because Whelen accessory brake lights may illuminate without the brake pedal being pressed.
The Company Store is recalling about 13,000 children's robes because they fail to meet federal flammability standards, posing a risk of burn injuries.
Lotus Foods is recalling rice ramen noodle soup cups because their labels incorrectly instruct consumers to use a microwave, posing fire and burn risks.
TJX is recalling glass and ceramic drawer knobs sold at T.J. Maxx, Marshalls, and HomeGoods because they can shatter when pulled, posing a laceration hazard.
Vermont Packinghouse is recalling raw bone-in beef quarters from cattle over 30 months old due to possible specified risk materials contamination.
Blue Bird is recalling 2016-2020 Vision transit buses because improperly routed brake lines and shifter cables may cause fluid or fuel leaks, increasing fire risk.
Invacare is recalling 73,703 hydraulic patient lifts because a mounting bolt may loosen, causing the caster to separate and the lift to tilt.
GE Healthcare is recalling CARESCAPE R860 Inspiratory Safety Guards because they may disconnect from the breathing circuit, potentially causing loss of ventilation and hypoxia in patients.
Zimmer Biomet is recalling 3,764 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging seal may compromise sterility.
Toyota, Lexus, and Pontiac are recalling specific 2002-2007 vehicles because passenger air bag inflators may explode during deployment, posing a risk of serious injury.
Harb Dairy is voluntarily recalling Green Cedar Ackawi cheese in Michigan after FDA and state officials confirmed the product tested positive for Listeria monocytogenes.
Agropur MSI Ingredients LLC is recalling Jay Robb Unflavored Egg White Protein due to undeclared milk. The recall covers 1,956 pouches distributed nationwide.
Philips is recalling 6,343 Brilliance 40 CT systems nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.
Blue Bird is recalling 2013-2020 Vision school buses because improperly routed brake lines and shifter cables may cause fluid or fuel leaks, increasing fire risk.
Ottogi America Inc. is recalling Ottogi Jin Ramen Mild 5-packs due to an undeclared egg allergen. The product was distributed in five U.S. states and Canada.
Zimmer Biomet is recalling 8,027 Humeral Guide Wires because creases in the sealing area may compromise product sterility.
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