Archive
1,028 recalls were announced in December 2014.
Of the 1,028 recalls this month scored against our rubric, 7% are Critical, 26% are Severe.
Which agencies issued them
Ethicon is recalling PERMA-HAND silk sutures because the company cannot ensure the products meet the expected sterility assurance level.
Customed, Inc. is recalling Wound Management Tray II units due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Zimmer CAS is recalling 15 PSI Knee System units due to a design flaw that could lead to misalignment during surgery.
Customed, Inc. is recalling Surgeon Reinforced Gowns XL because compromised sterility and manufacturing deficiencies may result in patient infection.
Chetak New York LLC is recalling Deep Raw Cashew Pieces because they may be contaminated with Salmonella. The recall covers 11,320 packages distributed nationwide.
Customed, Inc. is recalling surgical gowns due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Wound Management Tray III units because compromised sterility and manufacturing deficiencies may result in patient infection.
R and S Gourmet Warehouse is recalling Island Jerk Marinade because the product contains undeclared soy, wheat, and anchovies.
Customed, Inc. is recalling 1,050 Dressing Change kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Skin Staple Removal devices (Catalog 900-782) because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 2,670 surgical gowns because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.
Integra LifeSciences is recalling 6,358 Selector Kit tubing units because they may leak irrigation fluid during use if not placed correctly on the handpiece.
Customed, Inc. is recalling 36 orthopedic trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 160 Laparoscopy Gyn Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 156 Laparoscopy Packs (Catalog 900-1176) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 64 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 76 Cesarean Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Premier Research Labs is recalling Quantum Gallbladder Support capsules because they contain undeclared wheat, a major food allergen.
GCI Outdoor is recalling about 6,000 BleacherBack stadium seats because the backrest can fail, posing a risk of injury. Consumers should stop using the seats and contact the company for a repair kit.
Premier Research Labs is recalling BiliVen capsules because they contain undeclared wheat, a major allergen.
Real Foods LLC is recalling Chef Salad with Ham and Turkey because the product contains anchovies, an undeclared allergen, and is mislabeled with the wrong dressing.
Cure Medical is recalling pediatric urinary catheters because some boxes are mislabeled as size 8 but contain size 10 catheters, posing a risk of injury.
Teleflex Medical is recalling Aquapak nebulizer adaptors because packaging seals may be open or weak, potentially affecting the sterility of the device.
Customed, Inc. is recalling 140 ENT Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 2,520 surgical gowns because compromised sterility and inadequate storage conditions may increase the risk of patient infection.
Customed, Inc. is recalling 35 Endovenous Custom Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling 156 Universal Packs (Catalog 900-1587) because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.
Customed, Inc. is recalling 162 units of Peri Gyn Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling six Total Hysterectomy kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling 105 Plastic Surgery Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.
Bard Access Systems is recalling non-sterile GuardIVa Antimicrobial Hemostatic IV Dressing units that could potentially be used clinically.
Amerx Health Care Corp. is recalling Amerigel Hydrogel Wound Dressing units due to a formulation deviation. The recall covers 340,896 units distributed nationwide and internationally.
Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.
Customed, Inc. is recalling 176 D&C Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Alcon is recalling INFINITI Vision System Ultrasound FMS units because pieces of tubing may be present in the aspiration line.
Teleflex Medical is recalling Aquapak Nebulizer Adaptors because packaging seals may be open or weak, potentially compromising the sterility of the devices.
Beevers Manufacturing recalled 393 units of Cannulaide Model 101 because the product was packed and labeled as Model 102.
Amerx Health Care Corp. is recalling 1,740 units of Amerigel Daily Dressing Packets due to a formulation deviation. The affected products were distributed nationwide and internationally.
Coca-Cola is recalling specific lots of Dasani purified water because an equipment malfunction may have caused mold to appear in some bottles.
Stryker Neurovascular is recalling GDC 360 coils, Target coils, and Gateway PTA Balloon Catheters shipped beyond their expiration dates.
Stryker Neurovascular is recalling GDC 360 coils, Target coils, and Gateway PTA Balloon Catheters shipped to US customers beyond their expiration dates.
Amerx Health Care Corp. is recalling 79,677 Amerigel Post-op Surgical Kits due to a formulation deviation. The affected kits were distributed nationwide and internationally.
Stryker Neurovascular is recalling Gateway PTA Balloon Catheters shipped to US customers beyond their expiration date.
Microgenics Corporation is recalling 2,135 vials of MAS CardioImmune XL Cardiac Marker Control (Lot CXL16011) because the product shows vial-to-vial variation for specific analytes.
Siemens is recalling 1,131 Artis zee and zeego Angiography Systems due to a software issue that prevents deactivating the radiation block function after a network problem.
Stryker Neurovascular is recalling GDC 360 coils and related devices shipped to US customers beyond their expiration dates.
Sandoz, Inc. is recalling 6,336 bottles of 16 mg candesartan cilexetil tablets because stability testing showed impurity levels exceeded specifications.
Amerx Health Care Corp. is recalling 21,108 units of Amerigel Saturated Gauze Dressing due to a formulation deviation. The products were distributed nationwide and internationally.
Stryker Neurovascular is recalling Target Detachable Coils shipped to US customers beyond their expiration date.
Aesculap, Inc. is recalling three Dual Switch Valves due to incorrect expiration dates on inner sterile bag labels. No patient injuries have been reported.
CooperSurgical is recalling 30 units of the Cannula-Curette 12MM (Lot 147234) because the product contains an incorrect curette type.
Zydus Pharmaceuticals USA is recalling Benzonatate 200 mg capsules because they may contain foreign 100 mg capsules.
Cummins is recalling specific Ecofit Tier2 DOC raincaps because the lid may detach, posing a crash or injury risk.
Hyundai is recalling specific 2015 Sonata vehicles because an incorrect left axle shaft may separate from the transaxle, potentially causing the vehicle to stop moving or roll away.
Dream On Me is recalling approximately 10,000 Incredible Play Yards because the rails can collapse, posing a strangulation hazard to young children.
ARBOC is recalling 2015 Spirit of Mobility transit buses because driver-side windows lack required safety stamps, posing a glass shard injury risk.
Lenovo is recalling LS-15 AC power cords for laptops due to overheating risks that can cause fires and burns. Consumers should stop using the cords and contact Lenovo for a free replacement.
Starcraft RV is recalling 2015 Launch Ultra Lite travel trailers because tire labels list incorrect pressure information, which could lead to over-inflation and tire blowouts.
Nordstrom is recalling Leith brand open vest sweaters because they fail federal flammability standards, posing a burn injury risk. No injuries have been reported.
Halcore is recalling 55 AEV ambulances because a suspension fluid tank bracket may fail, causing the tank to separate and create a road hazard.
Pierce Manufacturing is recalling 2008-2011 Quantum fire apparatus because broken accelerator pedal springs may cause unintended acceleration, increasing crash risk.
Honda is recalling 2015 Acura TLX vehicles because a transmission defect may prevent the vehicle from engaging Park, increasing the risk of rolling away and crashing.
H&H Sports Protection is recalling 1,172 VCAN V528 motorcycle helmets because the retention systems failed high-temperature testing and required labeling is missing.
Kingmor is recalling 2006-2014 IC CE school buses equipped with certain Ricon wheelchair lifts because the platform side plates may crack, posing an injury risk.
Ford is recalling 2014 Transit Connect cargo vans because sliding door panels may separate while driving, increasing crash risk.
Velvac is recalling specific warning triangle kits that fail to meet Federal Motor Vehicle Safety Standard No. 125 requirements for stability and reflectivity.
Jayco is recalling 2015 Eagle HT FW 28.5RSTS "PR" trailers because incorrect tire size information on the label could lead to improper tire replacement and increased crash risk.
Ford is recalling 2015 Mustangs because a fuel pressure sensor may not be seated properly, causing a fuel leak that increases fire risk.
Doubletree RV is recalling 2006-2013 recreational trailers because a defect in the door locks may jam the deadbolt, potentially trapping occupants inside the vehicle.
Horizon Hobby is recalling HobbyZone Super Cub S power supplies and chargers because they can overcharge batteries, posing a fire and property damage risk.
Quality Meats, Inc. is recalling approximately 44,372 pounds of frozen pork belly because the product was not presented for USDA-FSIS import inspection.
Salsa Cycles is recalling approximately 2,500 Bearpaw bicycle forks because they may bend or break, posing a fall hazard to riders.
nSpired Natural Foods is recalling specific MaraNatha Organic Peanut Butter products due to potential Salmonella contamination. The products were distributed in the US, Canada, and other countries.
Kerry Foods is recalling specific lots of Chicken Noodle Soup Seasoning because the product contained an ingredient found positive for Salmonella.
nSpired Natural Foods is recalling Arrowhead Mills Organic Crunchy Peanut Butter No Salt Added due to potential Salmonella contamination.
nSpired Natural Foods is recalling MaraNatha Roasted Almond Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
nSpired Natural Foods is recalling MaraNatha Organic Creamy Peanut Butter products due to potential Salmonella contamination. The products were distributed in the United States, Canada, and other countries.
Kerry Foods is recalling specific lots of Chicken Noodle Soup because an ingredient tested positive for Salmonella.
nSpired Natural Foods is recalling MaraNatha Roasted Creamy Almond Butter No Sodium due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
nSpired Natural Foods is recalling MaraNatha Organic No Stir Creamy Peanut Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
nSpired Natural Foods is recalling specific lots of MaraNatha and Trader Joe's Raw Creamy Almond Butter due to potential Salmonella contamination. The products were distributed in the US, Canada, and other countries.
Kerry Foods is recalling specific lots of English Bread because they contained an ingredient found positive for Salmonella.
Kerry Foods is recalling specific lots of Brown Butter because an ingredient tested positive for Salmonella. The product was distributed in six US states and Canada.
nSpired Natural Foods is recalling MaraNatha Organic Raw Crunchy Almond Butter due to potential Salmonella contamination.
Kerry Foods is recalling specific lots of Breakfast Sausage Seasoning because the product contained an ingredient testing positive for Salmonella.
Lundberg Family Farms is recalling specific lots of Organic Brown Rice Flour after a customer reported a positive Salmonella test. The product was sold in bulk bins in five states.
Kerry Foods is recalling specific lots of Breakfast Sausage Seasoning because the product contained an ingredient found positive for Salmonella.
Kerry Foods is recalling specific lots of Rosemary & Olive Oil Seas Baptistas seasoning because an ingredient tested positive for Salmonella.
Kerry Foods is recalling specific lots of breakfast sausage because an ingredient tested positive for Salmonella.
Whole Foods Market is recalling Plain Streusel Coffeecake (no nuts) because it contains undeclared pecans, a major food allergen.
nSpired Natural Foods is recalling MaraNatha No Stir Crunchy Almond Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
nSpired Natural Foods is recalling MaraNatha Organic Roasted Crunchy Peanut Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
nSpired Natural Foods is recalling MaraNatha Organic No Stir Roasted Crunchy Peanut Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
International Sprout Holding Inc. is recalling organic alfalfa seed after an FDA sample tested positive for Salmonella. The product was distributed in nine US states and Canada.
nSpired Natural Foods is recalling MaraNatha Raw Almond Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
Wehah Farms is recalling 25 lb. bags of Organic Brown Rice Flour due to a positive Salmonella test. The product was distributed in bulk bins in CA, HI, AZ, MA, and NV.
nSpired Natural Foods is recalling MaraNatha Organic Roasted Crunchy Almond Butter due to potential Salmonella contamination. The product was distributed in the US, Canada, and other countries.
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