Archive
745 recalls were announced in November 2015.
Of the 745 recalls this month scored against our rubric, 3% are Critical, 56% are Severe.
Which agencies issued them
Innokas Medical is recalling 424 CARESCAPE VC150 Vital Signs Monitors because the devices may shut down unintentionally without restarting.
The Great Gourmet Inc is recalling Cheesy Crab & Bacon Bites because the labels fail to list wheat, a major allergen.
Tekia is recalling 50 units of Single Piece Hydrophilic Acrylic Intraocular Lenses because they may be labeled with the incorrect diopter power.
The Great Gourmet Inc is recalling specific crab and shrimp cake products because the labels fail to list wheat, a major allergen.
Instrumentation Industries Inc is recalling specific lots of reusable ventilator tubing due to a manufacturing defect that may cause layer delamination and leakage.
Forest River is recalling 2006-2014 Starcraft buses with Ricon wheelchair lifts where oversized pivot holes may allow bearings to shift, risking platform failure.
The Compounder is recalling specific lots of compounded hormone capsules because an active ingredient was contaminated with penicillin.
The Great Gourmet Inc is recalling three seafood products because their labels fail to list wheat, a major allergen.
WalkMed Infusion is recalling Triton Infusion Pumps because they may fail to detect air in the line when infusing Venofer.
DeRoyal Industries is recalling specific lots of sterile surgical kits containing 3M DuraPrep solution due to unintended exposure to sterilant during the sterilization process.
Ceterix Orthopedics is recalling 1,364 NovoCut Suture Manager devices because they may cut sutures during knot tensioning, causing knots to unravel.
GE Healthcare is recalling 55 SIGNA Excite 3.0T MR systems because displayed SAR values may be lower than actual head SAR levels during scans.
Synthes is recalling Small Notch Titanium Reconstructive Plate sets because they are being used in spine surgeries, which is a contraindicated use for these trauma products.
Micro Bird is recalling 2006-2014 school buses with Ricon wheelchair lifts where oversized pivot holes may allow bearings to shift, risking platform failure.
DeRoyal Industries is recalling 355 sterile surgical kits containing 3M DuraPrep solution due to unintended exposure to sterilant during package sterilization.
GE Healthcare is recalling 97 Signa HD 3.0T MRI systems because displayed SAR values may be lower than actual head SAR levels, potentially exceeding safety limits.
Forest River is recalling 2006-2014 Elkhart ECII transit buses because wheelchair lift bearings may move out of position, causing the platform to fall.
The Compounder is recalling Biest TD 86/14 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.
Stryker is recalling specific lots of Triathlon MIS Modular Distal Capture instruments because they may disassociate during use.
Teleflex Medical is recalling Roesch Flexi-Slip Endotracheal Tube Stylets because the plastic coating may split or break off.
GE Healthcare is recalling 17 SIGNA PET/MR 3.0T scanners because displayed SAR values may be lower than actual levels, potentially exceeding safety limits during head or neck scans.
GE Healthcare is recalling 350 Signa HDx 3.0T MRI scanners because displayed SAR values may be lower than actual head SAR levels, potentially exceeding safety limits.
Biomet 3i is recalling 96 dental driver tips because hexed tips were labeled as square tips, and square tips were marked with hexed identifiers.
Biocare Medical is recalling certain lots of Smooth Muscle Actin reagents because they may stain cell types that should be negative.
Focus Diagnostics is recalling 38 Anaplasma phagocytophilum IFA IgM Test Kits due to a potential increase in invalid results.
Utah Medical Products is recalling 21,403 Myelo-Nate CSF Sampling Kits because an internal inspection found a compromised sterile seal on one side of the tray.
C. O. Truxton is recalling 287 bottles of Doxycycline Hyclate Tablets, 100 mg, because the product bears the wrong bar code.
Cook Inc. is recalling specific lots of CXI Support Catheters because the 2.6FR curved and 4.0FR straight catheters were mixed during processing.
Boston Scientific is recalling three SQ-RX Model 1010 subcutaneous pulse generators shipped in dual-channel mode. This configuration may delay initial telemetry scans but does not affect therapy delivery.
Siemens Medical Solutions is recalling 15 Modularis VarioStar lithotripters because a display freeze prevents current treatment data from being shown to users.
Biomet 3i is recalling 103 Narrow Right Angle Square Driver Tips that were mislabeled as hexed tips, creating a risk of improper use during dental procedures.
Medtronic is recalling 496 Perfusion Tubing Packs due to a potential breach in the header bag seal. The affected lots were distributed nationwide in the US.
Beckman Coulter is recalling Access CEA Assay reagent packs because they were filled incorrectly. The recall covers 11,406 units distributed worldwide.
Stryker Spine is recalling 42 units of Radius Rod to Rod Connectors because the device lacks the required FDA 510(k) clearance.
Villa Radiology Systems LLC is recalling six Owandy Radiology I-MAX Touch 3D X-ray units because they lack required accompanying information documents.
Stryker Sustainability Solutions is recalling 1,202 reprocessed surgical drill bits and blades because packaging was not properly sealed.
CooperSurgical is recalling 144 MILEX Pessary Kits because the outer packaging displays incorrect size prints, although the pessary pouch itself is correctly marked.
Villa Radiology Systems LLC is recalling eight Rotograph EVO 3D X-ray units because accompanying documents are missing, causing non-compliance with FDA regulations.
Breckenridge Pharmaceutical is recalling 595 bottles of Duloxetine 60 mg capsules because one bottle contained a foreign omeprazole 10 mg capsule.
Airstream is recalling 904 model year 2016 recreational trailers because propane gas may leak from the regulator, increasing the risk of a fire.
PetSmart is recalling Grreat Choice and Top Fin glass fish bowls because they can shatter during normal handling, posing a laceration risk.
EverGreen is recalling 2013-2015 recreational vehicles equipped with Atwood water heaters that may overheat, posing a scalding risk.
REI is recalling evrgrn Campfire Rocker Chairs because they can tip backwards while rocking, posing a fall hazard to users.
M.B. Sturgis is recalling specific Auto Changeover Regulators for propane gas cylinders due to a risk of gas leaks and fire.
Keystone RV is recalling 2015-2016 Dutchmen Voltage trailers because the exterior folding ladder may not be properly secured, posing an injury risk.
PetSmart is recalling Top Fin Betta Bowl Kits with LED lights because the glass bowls can crack or shatter, posing a laceration hazard.
Kona is recalling about 530 2014 Wo bicycles because the fork can crack or break, posing a fall hazard. Consumers should stop using the bikes and contact Kona for a free replacement.
Mobility Specialists is recalling 2006-2014 Ford E-250 and E-350 vans with Ricon wheelchair lifts. The platform side plates may crack or bearings may shift, causing the lift to fall and injure the operator.
Tyson Foods is recalling approximately 52,486 pounds of fully cooked hot wings due to possible adulteration from an off odor.
Navistar is recalling 2014-2015 International TranStar trucks because a turbocharger oil line may leak near the exhaust, increasing fire risk.
Hyundai is recalling 2011-2012 Sonata vehicles because a deteriorating brake pedal stopper pad may prevent the brake light switch from retracting, increasing crash risk.
Hyundai is recalling 2013-2015 Genesis Coupes with manual transmissions because rear differential bolts may loosen, potentially causing loss of propulsion and increased crash risk.
Pierce is recalling 2013-2015 fire-fighting vehicles because water pressure regulators may fail, causing unexpected surges that could injure operators.
Champion is recalling 2006-2015 transit buses equipped with specific wheelchair lifts where oversized pivot holes may allow bearings to move, risking platform failure and injury.
Winnebago is recalling specific 2015-2016 motorhomes because a water heater valve may cause water to overheat, potentially releasing steam and scalding users.
Trails West is recalling 2015-2016 trailers because a weld on the rear axle may fail, causing the wheel assembly to separate and increasing crash risk.
Daimler Trucks North America is recalling 27 model year 2016 Minotour school buses because an incorrectly routed wiring harness may cause a loose power cable, increasing the risk of an electrical arc and fire.
Allied Recreation Group is recalling 2016 Fleetwood Southwind motorhomes because a gas valve defect may cause the water heater to overheat, posing a scalding risk.
Newmar is recalling certain 2004-2008 Essex, London Aire, and Mountain Aire motorhomes because the engine cooling fan may separate from the drive, posing an injury risk to nearby individuals.
Graco is recalling specific Milestone child seats because they lack a required label phrase regarding LATCH system usage. Owners will receive free replacement labels.
WakaWaka is recalling electrical adapter kits because they can overheat, smoke, or explode, posing risks of fire and electrical shock. No injuries have been reported.
Goshen Coach is recalling 2006-2015 buses equipped with certain Ricon wheelchair lifts due to a defect that could cause the platform to fall out of the vehicle.
Family Dollar is recalling about 32,000 ceramic wax warmer sets sold nationwide because they can produce high flames, posing fire and burn risks.
SharkNinja is recalling Ninja BL660 series blenders because the loose blade assembly poses a laceration risk if the pitcher is inverted. Consumers should follow new instructions to prevent injury.
Eldorado is recalling 2006-2015 shuttle buses equipped with specific Ricon wheelchair lifts. The defect may cause the lift platform to fall out of the vehicle, increasing injury risk.
STIHL is recalling about 140,000 gas-powered edgers, trimmers, and pruners because a defective fuel tank vent can leak gasoline, creating a fire risk.
PNY is recalling T10400 portable battery packs because they can overheat and vent flames, posing fire and burn hazards.
Mahindra USA is recalling about 2,000 eMax compact tractors because fuel lines can break or leak, posing a fire hazard. No injuries have been reported.
Newmar is recalling 2014-2016 Canyon Star motorhomes because a water heater valve defect may cause water to overheat, posing a scalding risk to users.
Winnebago is recalling specific 2008-2012 recreational vehicles because wheelchair lift bearings may shift, causing the platform to fall and injure the operator.
Specialty Manufacturing Co. is recalling Transpec school bus stop arms because a reflective decal may peel loose, reducing visibility and increasing crash risk.
Hilltop Farm is recalling 18 clamshells of Spicy Mix Hydroponic Micro Greens sold in Texas because the product tested positive for Salmonella.
Hamilton Medical is recalling 1,128 HAMILTON-G5 ventilators because suctioning maneuvers can unintentionally suppress ventilation and alarms.
Whole Foods Market is recalling Organic Roquefort Papillon cheese due to potential contamination with Listeria monocytogenes.
Aksar LLC is recalling Cashew Pieces after a sample tested positive for Salmonella. The product was distributed in Virginia, Maryland, and North Carolina.
Texas Star Nut and Food Co. is recalling Southern Grove Simply Raw Trail Mix because the product tested positive for Salmonella.
Hilltop Farm is recalling 12 clamshells of Giant Red Mustard Hydroponic Micro Greens in Texas due to a Salmonella positive result.
Texas Star Nut and Food Co. is recalling Nature's Eat Natural Macadamia Nuts because the product tested positive for Salmonella.
Bard Peripheral Vascular is recalling 292 units of the FLAIR Endovascular Stent Graft due to potential deployment failures during use.
Biscomerica, Inc. is recalling specific lots of cocoa buttons because they contain undeclared milk. The product was distributed in Ohio.
Shearer's Foods is recalling On The Border Cafe Style Tortilla Chips because they may have been exposed to a milk-containing ingredient.
Nijay International is recalling specific lots of Organic Coriander Powder due to potential Salmonella contamination. The product was distributed in Texas.
MBG Marketing is recalling select pallets of Naturipe IQF Blueberries due to the potential presence of Salmonella.
Greencore USA is recalling Evolution Fresh Nonfat Greek Yogurt with Strawberry and Granola because it may contain undeclared almonds.
A.M.S. Exotic LLC is recalling Earth Exotic Brussels Sprouts due to potential Listeria monocytogenes contamination. The product was distributed in Connecticut and South Carolina.
Del Monte Fresh Produce is recalling 5,962 Granny Smith apples in eight states due to potential Listeria monocytogenes contamination.
JP Trading and Global Imports LLC is recalling 80 cases of Tradiciones Andinas Peeled Mote Corn because the product contains sulfites that are not listed on the label.
Krispy Kreme is recalling glazed doughnuts with kreme filling because they may contain glass. Consumers should check for lot code 10/18/15.
Kontos Foods Inc. is recalling 3,392 tubs of Kontos Falafel Mix nationwide due to undeclared wheat allergen.
ConMed is recalling 276 Arthroscopic Energy 50 Probes with Suction because a programming error may generate excess heat, increasing the risk of tissue damage during surgery.
Krispy Kreme Doughnut Corporation is recalling Chocolate Iced Glazed Doughnuts because they may contain glass. Consumers should stop eating these products.
Krispy Kreme Doughnut Corporation is recalling specific lots of Chocolate Iced Doughnuts with Kreme Filling because they may contain glass.
Krispy Kreme is recalling Signature Doughnuts, Half Dozen, due to the potential presence of glass. Consumers should discard the product.
Medtronic is recalling 64 units of Achieve Electrical Cables (Model 990066) due to a potential sterility breach. The sterile, single-use cables were distributed to facilities in 16 states and DC.
Krispy Kreme is recalling specific lots of Glazed Raspberry Filled Doughnuts because they may contain glass.
Krispy Kreme is recalling Original Glazed Doughnut Holes because the finished product may contain foreign matter, specifically glass.
Mako Surgical Corporation is recalling RIO system locking pins and connectors because the pins are damaged during assembly.
Siemens Medical Solutions is recalling e.cam Gamma Camera systems due to a potential radial brake failure that could allow the detector to drift.
Brainlab AG is recalling Patient Data Manager software versions 2.0.0 through 2.1.0 because objects may display incorrectly when users deselect fused reference datasets.
Philips is recalling HeartStart MRx monitor/defibrillators because they may reboot unexpectedly, interrupting or delaying therapy.
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