Hysteroscope Model HYF-1T recalled due to moisture in device channels
Aizu Olympus is recalling Hysteroscope Model HYF-1T devices because the channel air drying process after repair was not validated. Some returned units had residual moisture that could allow contamination and infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm medical device where no infections have been reported. The FDA Class II designation without reported hospitalizations or injuries does not meet the Severe threshold. The potential for infection exists but is theoretical, placing this at High severity.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling the Hysteroscope Model HYF-1T (UDI-DI: 04953170051128), a device used for endoscopic diagnosis within the uterus. The recall affects units distributed nationwide in the US and worldwide.
The manufacturer determined that the channel air drying process used after device repair was not validated. As a result, a small percentage of scopes returned to customers after repair contained residual water in the channels.
Water remaining in the endoscope channels creates potential for microbial contamination, which could lead to infection in patients.
Healthcare providers and facilities using this device should contact the manufacturer for specific instructions on affected units and recommended corrective actions.
The recalled product
- Product
- Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
- Manufacturer
- Aizu Olympus Co., Ltd.
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-1T (04953170051128).
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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