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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
There is a potential for blood backfill leakage and foreign material.
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.
Centered glenosphere box may contain an eccentric glenosphere.
A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.
There is a potential for blood backfill leakage and foreign material.
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site
The sterile blister packaging may be damaged, and sterility may be compromised
Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.
The sterile blister packaging may be damaged, and sterility may be compromised
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery