Olympus recalls ureteralscopes URF-P6 and URF-P6R models due to potential water contamination in the channel after repair, which could lead to infection. Affected units were sold with specific model numbers and UDI codes.
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
Olympus is recalling ureteralscopes URF-P6 and U:RF-P6R models because water in the channel after repair could cause infection. This is a serious risk for medical users who might not notice the contamination.
The channel air drying process wasn't properly validated, so some scopes after repair had water remaining. This water could lead to contamination and infection if the scope is used without proper cleaning.
Medical professionals using these ureteralscopes for endoscopic procedures are most at risk. Patients undergoing treatments with these devices could be exposed to infection if the channel is contaminated.
Check for model numbers URF-P6 or URF-P6R on the device. The UDI codes 04953170340802 and 04953170340833 indicate affected units. These scopes were sold for endoscopic procedures in the ureter, kidney, and biliary tract.
Inspect the channel for water residue after use. If water is present, stop using the scope immediately.
Reach out to Olympus directly for guidance on safe handling or repair options.
The affected models are URF-P6 and URF-P6R with UDI codes 04953170340802 and 04953170340833.
Check for water residue in the channel after use. If water is present, the scope may be contaminated and should not be used.
The recall does not specify a fix; users should contact Olympus for guidance on safe handling or repair.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0347-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0347-2024 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
