RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026da VinciOfficial source

    da Vinci S/Si Harmonic ACE Insert recall in Canada: sterility breach risk

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    In plain language

    This recall involves da Vinci S/Si Harmonic ACE Inserts sold in Canada. They are being recalled because their packaging may have small holes, which could lead to a breach in sterility. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the lot numbers provided.
    • Return the product as instructed.

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    Affected products

    • da Vinci S/Si Harmonic ACE Insert

      Model: 400272

      Lot: M10171101, M10171208, M10171220, M10180103, M10180403, M10180417, M10180802

    Why this matters

    Sterility breach risk

    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: M10171101, M10171208, M10171220, M10180103, M10180403, M10180417, M10180802

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 400272

    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?

    Sterility breach risk

    What should consumers do?

    Stop using the product immediately. Check the lot numbers provided. Return the product as instructed.

    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 breach risk

    When was this product recalled?

    This product was recalled on January 31, 2019.

    Is the da Vinci brand affected by this recall?

    Yes, da Vinci products are affected by this recall. This recall involves da Vinci S/Si Harmonic ACE Inserts sold in Canada. They are being recalled because their packaging may have small holes, which could lead to a breach in sterility. Stop using the product and follow the return steps in the official notice.