Ureteralscope- for endoscopic diagnosis and treatment within the… — Class II medical device recall Z-0347-2024
Ongoing recall by Aizu Olympus Co., Ltd., reported 2023-11-29, distributed nationwide. Channel air drying process was not validated, and that a small percentage of scopes returned to customers afte
| Recall number | Z-0347-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aizu Olympus Co., Ltd., Aizuwakamatsu, N/A, Japan |
| Recall initiated | 2023-09-25 |
| Classified | 2023-11-17 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,577 units |
| UPC / GTIN / UDI-DI | 04953170340802, 04953170340833 |
| Model numbers | URF-P6, URF-P6R |
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.
Reason for recall
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.