Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

Reason: 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

Code information: Model Number (UDI-DI): HYF-XP (04953170340178).

Distribution pattern: Worldwide - US Nationwide distribution.