Olympus recalls Soltive SuperPulsed Laser System TFL Fiber Cleavers (model TFL-AFC) sold before 2023 due to non-sterile design risking contamination during medical procedures.
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
Olymp: Olympus is recalling Soltive SuperPulsed Laser System TFL Fiber Cleavers (model TFL-AFC) sold before 2023 because they are non-sterile and labeled as reusable, which could contaminate sterile medical fibers during procedures.
The cleavers are labeled as reusable and autoclavable but lack validated cleaning and sterilization instructions. Using them on sterile medical fibers without proper sterilization risks contamination, potentially leading to infections.
Healthcare professionals using the Soltive SuperPulsed Laser System TFL Fiber Cleavers for medical procedures are most at risk. Patients undergoing procedures with these devices could be exposed to contamination.
Check for the model number TFL-AFC on the device. Units sold before 2023 are affected. The product is used in medical laser procedures.
Look for the model number TFL-AFC on the Soltive SuperPulsed Laser System TFL Fiber Cleaver.
Reach out to Olympus Corporation of the Americas for guidance on next steps.
The cleavers are non-sterile and labeled as reusable but lack validated cleaning and sterilization instructions, risking contamination during medical procedures.
Yes, using non-sterile cleavers on sterile medical fibers could lead to contamination and potential infections.
Check for the model number TFL-AFC and ensure it was sold before 2023.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0717-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0717-2024 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.
