Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 28 recalls
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Potential breach in pouch packaging which could lead to loss of sterility.
Potential breach in pouch packaging which could lead to loss of sterility.
Potential breach in pouch packaging which could lead to loss of sterility.
Potential breach in pouch packaging which could lead to loss of sterility.
Potential breach in pouch packaging which could lead to loss of sterility.