Olympus recalls Choleodochoscope models CHF-BP30, CHF-CB30L, and CHF-P60 due to potential water contamination leading to infection risks. Affected units may have wet channels after repair.
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 three choleodochoscope models because water in the channel after repair could lead to infections. This risk applies to medical devices used in procedures like bile duct imaging.
Water remaining in the channel after repair can cause contamination. This contamination may lead to infections if the device is used without proper sterilization.
Healthcare professionals using the Choleodochoscope for medical procedures are most at risk. Patients receiving these procedures may also be affected if the device is used without proper cleaning.
Check for model numbers CHF-BP30, CHF-CB30L, or CHF-P60 on the device. The product was sold with specific UDI-DI numbers listed in the recall notice.
Identify the model number on the device to confirm if it is one of the recalled models: CHF-BP30, CHF-CB30L, or CHF-P60.
The recall is due to water remaining in the channel after repair, which could lead to contamination and infection risks.
Check the model number on your device. Affected models are CHF-BP30, CHF-CB30L, or CHF-P60.
The recall notice does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0330-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0330-2024 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.
