Olympus recalls specific colonoscope models due to potential water contamination in the channel after repair, which could lead to infection. Affected models include CF-2T160I, CF-2T160L, and others.
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 certain colonoscopes used for lower digestive tract procedures because water in the channel after repair may cause infection. This risk occurs when the device is not properly dried following maintenance.
The channel air drying process was not validated, so a small percentage of scopes returned after repair had water remaining. This water could lead to contamination and infection if the device is used without proper cleaning.
Medical professionals who use the recalled colonoscopes for endoscopy or surgery are most at risk. Patients who have had procedures with these models may also be affected.
Check for model numbers CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, and CF-Q180AL. These models were sold with specific UDI-DI numbers.
Identify your colonoscope's model number from the product list provided in the recall notice.
Reach out to Olympus directly for guidance on whether your device is affected and next steps.
The channel air drying process was not validated, so a small percentage of scopes returned after repair had water remaining, which could lead to contamination and infection.
Check for model numbers listed in the recall: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, and CF-Q180AL.
Contact Olympus directly to determine if your device is affected and follow their instructions for next steps.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0329-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0329-2024 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.
