Home / Recalls / Medical Devices
Aizu Olympus Co., Ltd. recalls Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Recalled November 29, 2023 · FDA recall Z-0337-2024 · Aizu Olympus
Hazard
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 · FDA Class II
Units
16 units
Sold at
Worldwide - US Nationwide distribution.
Description
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
Product
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Manufacturer(s)
Aizu Olympus Co., Ltd.
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →