Olympus ViziShot 2FLEX Biopsy Device Recalled for Deformed Tips in 103,731 Units
Potential for undetected, deformed a-traumatic tips.
1,079 recalls tagged with “chemical hazard”.
Potential for undetected, deformed a-traumatic tips.
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: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
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.
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
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Enoxaparin Sodium Injection recall active as of 2025. Cardinal Health and Sandoz Inc. distributed the product in Kansas. Bags labeled 80 mg/0.8 mL contained 30 mg/0.3 mL doses. Health authorities urge immediate stop-use and guidance from providers.
AVID Medical recalled 57 JACK421-04 ENT PACK convenience kits nationwide in Florida. The open header bag seals could compromise sterility. Consumers should stop using the device and follow manufacturer instructions for recall resolution.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
AVID Medical recalls 228 CPT BASIC IR PACKs sold nationwide, including Florida, due to open header bag seals that may compromise sterility. The recall is active as of September 17, 2025. Consumers should stop use and follow manufacturer instructions.
Lack of Assurance of Sterility.