Recalls for Cystourethroscope

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

The surgical gowns were manufactured in a facility that is not registered by the FDA.