🏥 Medical Devices Class I - Dangerous
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
All Recalls
95,102 total recalls in our database
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).
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
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).
🏥 Medical Devices Class I - Dangerous
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.
S. Typhi/Para Typhi A Antigen
Changchun Wancheng Bio-Electron Co.
🏥 Medical Devices Class I - Dangerous
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.
🍎 Food Class I - Dangerous
Undeclared wheat.
Potential contamination with biological hazards (Listeria monocytogenes).
Potential contamination with biological hazards (Listeria monocytogenes).
🍎 Food Class I - Dangerous
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).
🍎 Food Class I - Dangerous
Product is labeled as decaf, but might contain caffeine.
Potential contamination with biological hazards (Listeria monocytogenes).
Products may be contaminated with Salmonella Typhimurium
🍎 Food Class I - Dangerous
Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.
🍎 Food Class I - Dangerous
Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.