Olympus recalls specific bronchoscope models due to potential water contamination after repair, risking infection. Affected models include BF-1T150, BF-1T60, and others. Contact Olympus for details.
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 bronchoscope models used in airway procedures because water can remain in the device after repair, creating a risk of infection. This affects medical professionals and hospitals that use these scopes for endoscopy and surgery.
The channel air drying process for these bronchoscopes wasn't properly validated. After repair, a small percentage of scopes had water remaining in the channel, which could lead to contamination and infection if the device is used without proper cleaning.
Healthcare providers and hospitals that use Olympus bronchoscopes for endoscopy and surgery are most at risk. The recall applies to specific model numbers listed in the notice.
Check if your bronchoscope has model numbers BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, or BF-XT190. These models were sold with the specified 510(k) numbers.
Identify the model number on your bronchoscope to confirm if it is listed in the recall.
Reach out to Olympus directly for instructions on how to return or repair the device.
Olympus is recalling these models because water can remain in the channel after repair, creating a risk of contamination and infection.
The affected models include BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, and BF-XT190.
The recall states a risk of infection, not serious injury. The hazard is low risk as it relates to contamination after repair, not immediate harm.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0327-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0327-2024 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.
