95,064 total recalls in our database
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
VANTIVE US HEALTHCARE
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
Changchun Wancheng Bio-Electron Co.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Undeclared wheat.
Potential contamination with biological hazards (Listeria monocytogenes).
Potential contamination with biological hazards (Listeria monocytogenes).
Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.
Potential contamination with biological hazards (Listeria monocytogenes).
Potential contamination with biological hazards (Listeria monocytogenes).
Potential contamination with biological hazards (Listeria monocytogenes).
Potential contamination with biological hazards (Listeria monocytogenes).
Product is labeled as decaf, but might contain caffeine.
Potential contamination with biological hazards (Listeria monocytogenes).
Products may be contaminated with Salmonella Typhimurium