RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Gyrus Acmi, IncOfficial source

    TFL Fiber Cleaver and Stripper recall in Canada: Sterility issue

    Share:

    In plain language

    This recall involves TFL Fiber Cleavers and Strippers sold in Canada. They are being recalled because they are provided non-sterile and lack validated cleaning and sterilization instructions. Using a non-sterile device on a sterile fiber could cause contamination. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Contact the manufacturer for additional information.

    Get alerts for recalls like this

    Get email alerts when new recalls affect products in this category.

    Categories (optional)

    No spam. Unsubscribe anytime. We only email when there's a relevant recall.

    Affected products

    • TFL Fiber Cleaver

      Model: TFL-AFC

      Lot: All lots

    • TFL Fiber Stripper

      Model: TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940

      Lot: All lots

    Why this matters

    Contamination risk due to sterility issue

    Do I have this product?

    This recall only applies to specific products. Follow the steps below to check.

    1. 1

      Check the product name

      Make sure your product name matches one of the affected products listed above.

    2. 2

      Check the lot number

      Lot numbers identify specific production batches.

      Affected lots: All lots

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: TFL-AFC, TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940

    If your product matches one or more of the details above, it may be affected by this recall.

    If your product does not match these details, it is not affected by this recall.

    When in doubt, always check the official notice.

    Want alerts if similar products are recalled in Canada?

    Frequently Asked Questions

    Why was this product recalled?

    Contamination risk due to sterility issue

    What should consumers do?

    Stop using the product immediately. Contact the manufacturer for additional information.

    Where was the product sold?

    This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.

    Is there a health risk?

    Yes, there may be a health risk. Contamination risk due to sterility issue

    When was this product recalled?

    This product was recalled on December 27, 2023.

    Is the Gyrus Acmi, Inc brand affected by this recall?

    Yes, Gyrus Acmi, Inc products are affected by this recall. This recall involves TFL Fiber Cleavers and Strippers sold in Canada. They are being recalled because they are provided non-sterile and lack validated cleaning and sterilization instructions. Using a non-sterile device on a sterile fiber could cause contamination. Stop using the product and contact the manufacturer for more information.