Olympus recalls EVIS EXERA BF-XT160 bronchoscopy scopes due to potential insertion tube leaks causing infection control risks. Affected units sold in the U.S. from 2019 to 2023.
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
Olympus is recalling its EVIS EXERA BF-XT160 bronchoscopy scopes because a manufacturing step was skipped, which could cause the insertion tube to leak and create infection risks. This affects medical devices used during procedures like bronchoscopy.
During manufacturing, a gluing step was skipped for the insertion tube. This can cause the tube to leak, potentially introducing infections during medical procedures. The risk is specific to the device's use in clinical settings.
Healthcare professionals using the EVIS EXERA BF-XT160 bronchoscopy scopes for procedures like bronchoscopy are most at risk. Patients undergoing these procedures may also be affected if the device leaks.
Check for the model number BF-XT160 on the device. The product was sold in the U.S. between 2019 and 2023.
Look for the model number BF-XT160 on the device to confirm if it is affected.
The device may have a leak risk due to a skipped manufacturing step, so it is not safe to use without checking the model number.
Check for the model number BF-XT160 on the device. The product was sold in the U.S. between 2019 and 2023.
The recall 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-2497-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2497-2021 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.
