Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.

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-1T (04953170051128).

Distribution pattern: Worldwide - US Nationwide distribution.