Hysterofiberscope Model HYF-XP Channel Drying Process Flaw Poses Infection Risk
Aizu Olympus is recalling HYF-XP hysterofiberscopes because the channel air drying process was not validated. Some repaired units have wet channels that could harbor contamination and pose infection risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries to date. The hazard—potential water contamination in endoscope channels leading to infection risk—represents a risk-of-harm scenario without reported injury. Per the rubric, such products score at 3 (High).
Plain-English summary
Aizu Olympus Co., Ltd. is recalling the HYF-XP Hysterofiberscope (Model Number HYF-XP, UDI-DI 04953170340178), a medical endoscope used for diagnostic examination within the uterus. The company discovered that the channel air drying process was not properly validated during manufacturing and maintenance procedures.
A small percentage of these devices that were returned to customers following repair were found to have wet channels. Water remaining in the endoscope's internal channels has the potential to become contaminated, which could lead to infection risk during clinical use.
Approximately 16 units have been distributed worldwide, including throughout the United States. Healthcare facilities and clinicians using this device should verify the condition of their equipment and contact the manufacturer for instructions on proper channel drying verification, inspection, cleaning, or replacement.
If you are using or have access to this device, contact Aizu Olympus Co., Ltd. immediately for further guidance.
The recalled product
- Product
- Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Hazard
- contamination
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number (UDI-DI): HYF-XP (04953170340178).
Distribution
Distributed nationwide across the United States.
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