Olympus recalls Soltive SuperPulsed Laser Fiber Strippers (models TFL-AFS150-550) sold before 2023 due to non-sterile design risking contamination when used on sterile fibers.
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.
Olympus is recalling Soltive SuperPulsed Laser Fiber Strippers (models TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940) sold before 2023. These strippers are labeled as reusable but lack validated sterilization instructions, creating a risk of contamination when used on sterile fibers.
The strippers are labeled as reusable and autoclavable but lack validated cleaning and sterilization instructions. Using them on sterile fibers can introduce contaminants, potentially causing infections or other complications.
Users of the Soltive SuperPulsed Laser Fiber Strippers sold before 2023 are affected. Medical professionals using these devices for sterile fiber procedures face the highest risk of contamination.
Check for model numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, or TFL-AFS940 on the device. The product was sold before 2023.
Identify the model number on the device to confirm if it is one of the recalled models (TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940).
Confirm the device was purchased before 2023 to determine if it falls under the recall.
The strippers are labeled as reusable but lack validated cleaning and sterilization instructions, posing a risk of contamination when used on sterile fibers.
The affected models are TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, and TFL-AFS940.
The recall does not require immediate discontinuation; users should check if their device is affected before taking action.
The recall record does not specify a replacement option or remedy.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0716-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0716-2024 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.
