Medical devicesUpdated Jan 3, 2026Gyrus Acmi, IncOfficial source

    SOLTIVE™ SuperPulsed Laser Ball Tip Fiber recall in Canada: Sterility issue

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    In plain language

    This recall involves SOLTIVE™ SuperPulsed Laser Ball Tip Fiber Single Use sold in Canada. It's being recalled because the sterile pouch seal may be breached, which could lead to sterility issues. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Review the notice.
    • Quarantine and return affected product.
    • Complete and return the online response form.

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    Affected products

    • SOLTIVE™ SuperPulsed Laser Ball Tip Fiber Single Use

      Model: TFL-FBX200BS

      Lot: KR262848

    Why this matters

    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: KR262848

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: TFL-FBX200BS

    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.

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    Frequently Asked Questions

    Why was this product recalled?

    Sterility issue

    What should consumers do?

    Stop using the product immediately. Review the notice. Quarantine and return affected product. Complete and return the online response form.

    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. Sterility issue

    When was this product recalled?

    This product was recalled on January 4, 2024.

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

    Yes, Gyrus Acmi, Inc products are affected by this recall. This recall involves SOLTIVE™ SuperPulsed Laser Ball Tip Fiber Single Use sold in Canada. It's being recalled because the sterile pouch seal may be breached, which could lead to sterility issues. Stop using the product and follow the return steps in the official notice.