Olympus recalls LTF-S190-10 endoscopy videoscopes due to reprocessing instructions error. Affected units may cause improper cleaning if not followed correctly.
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
Olympus is recalling its LTF-S190-10 endoscopy videoscopes because improper reprocessing could lead to contamination. This affects medical professionals using the device during surgeries.
The videoscope requires specific reprocessing steps to prevent contamination. If these steps aren't followed correctly, the device could become contaminated during use.
Medical professionals who use the Olympus LTF-S19:10 endoscopy videoscopes during surgery are most at risk. The recall applies to all units sold with the specific model number.
Check for the model number LTF-S190-10 on the device. The recall includes all units sold with this model and the UDI-DI number 04953170310386.
Review the Reprocessing Manual Instructions for proper cleaning steps to avoid contamination.
No, this recall is for medical use only during endoscopic surgery procedures.
Look for the model number LTF-S190-10 and the UDI-DI number 04953170310386 on the device.
Follow the Reprocessing Manual Instructions to ensure proper cleaning and avoid contamination risks.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0645-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0645-2024 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.