Ureteralscopes recalled due to unvalidated drying process and contamination risk
Aizu Olympus is recalling 1577 ureteralscope units due to an unvalidated channel air drying process that left some units with residual water after repair, creating a contamination and 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 device poses a theoretical risk of infection from residual water contamination, but no illnesses or injuries are documented in the source material. FDA Class II recalls without confirmed harm are classified as High severity per the rubric.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling 1577 ureteralscope units (Model Numbers URF-P6 and URF-P6R). These devices are used for endoscopic diagnosis and treatment within the ureter, kidney, and biliary tract.
The manufacturer's channel air drying process was not validated. A small percentage of scopes returned to customers after repair had residual water remaining in their channels. This moisture creates a potential for contamination that could lead to infection risk.
The affected units were distributed worldwide with US nationwide distribution.
For more information about this recall, refer to FDA recall number Z-0347-2024.
The recalled product
- Product
- Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Hazard
- water-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 (2)
- Model Number (UDI-DI): URF-P6 (04953170340802)
- URF-P6R (04953170340833).
Distribution
Distributed nationwide across the United States.
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