Loading...
Loading...
All product recalls affecting Louisiana.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Louisiana in the distribution area.
The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.
A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Discoloration: Dotted and yellow spots on tablets
Discoloration: Dotted and yellow spots on tablets
BMW of North America, LLC (BMW) is recalling certain 2014-2015 2 Series Coupe (228i, 228i xDrive, M235i), 3 Series Sedan (320i, 320i xDrive, 328i, 328i xDrive, 335i, 335i xDrive, M3, 328d, 328d xDrive), 4 Series Coupe (428i, 428i xDrive, 435i, 435i xDrive, M4), and 2015 4 Series Gran Coupe (428i, 428i xDrive, 435i, 435i xDrive) vehicles. The head air bag inflator may fail at the weld joint, which can cause gas to leak from the inflator or result in an inflator rupture.
Alliance RV, LLC (Alliance) is recalling certain 2022 Paradigm 295MK, and Avenue 32RLS fifth wheels. The freshwater tank may be installed incorrectly, which can result in the tank detaching from the vehicle.
There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Rocky Mountain ATV/MC, Inc. (RMATV) is recalling certain Tusk 2Track Adventure rear motorcycle tires, size 150/70B-18. The tread layer was improperly cured, which can result in sections of tread detaching from the tire.
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Kia America, Inc. (Kia) is recalling certain 2024 Sorento vehicles. The motor driven power steering (MDPS) wiring harness may be incorrectly assembled, which can result in a loss of power steering assist.
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Some applicator tips from these lots had open seals.
Winnebago Towable (Winnebago) is recalling certain 2022-2024 Voyage, Micro Minnie, Micro Minnie FLX, Hike 200 and Minnie travel trailers. The LED backlight circuit board in the cooktop range may fail, causing the board to overheat.
The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.