Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–4 of 4 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.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.