Olympus ViziShot 2FLEX Biopsy Device Recalled for Deformed Tips in 103,731 Units
Potential for undetected, deformed a-traumatic tips.
These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.
Immediate attention
Potential for undetected, deformed a-traumatic tips.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims and Misbranded.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims and Misbranded.
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Unapproved Drug Claims and Misbranded.
Maquet Cardiovascular recalled 98 Vasoview Hemopro 3 EVH systems nationwide across FL, IL, MD and TX after 16 out-of-box failure complaints. No serious injuries were reported. The failures occurred during limited launch before clinical use.