Hysterovideoscope Models Recalled Due to Improper Channel Drying Risk
Aizu Olympus is recalling Hysterovideoscope Model HYF-V units (27 devices) because the channel air drying process was not validated. Water remaining in device channels could pose an 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 a Class II recall of medical devices with theoretical risk of infection from water contamination. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are scored High (3).
Plain-English summary
Aizu Olympus Co., Ltd. is recalling Hysterovideoscope Model HYF-V devices used for endoscopic diagnosis within the uterus. The recall affects 27 units with worldwide distribution, including US nationwide availability.
The device channel air drying process was not properly validated. This validation failure resulted in a small percentage of scopes returned to customers after repair containing water in the channels.
Water remaining in the device channels creates a potential for contamination that could lead to infection risk. Customers should contact their healthcare provider or Aizu Olympus for guidance regarding affected devices.
The recalled product
- Product
- Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Affected units
- 27
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-V (04953170340185).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Aizu Olympus Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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