RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026SonopetOfficial source

    Sonopet recall in Canada: Not for uterine fibroid procedures

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    In plain language

    This recall involves Sonopet Main Unit, Universal, and Universal Handpiece medical devices sold in Canada. They are being recalled because they should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids. Stop using the product for these procedures and follow the instructions from Health Canada.

    What to do

    • Stop using the product for uterine fibroid procedures.
    • Consult the official Health Canada notice for further guidance.

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    Affected products

    • Sonopet Main Unit

      Model: 5450-850-000

      Lot: All lots.

    • Sonopet Universal

      Model: 5450-820-000

      Lot: All lots.

    • Sonopet Universal Handpiece

      Model: 5450-840-000

      Lot: All lots.

    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: 5450-820-000, 5450-840-000, 5450-850-000

    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?

    This recall involves Sonopet Main Unit, Universal, and Universal Handpiece medical devices sold in Canada. They are being recalled because they should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids. Stop using the product for these procedures and follow the instructions from Health Canada.

    What should consumers do?

    Stop using the product for uterine fibroid procedures. Consult the official Health Canada notice for further guidance.

    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?

    A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.

    When was this product recalled?

    This product was recalled on April 3, 2018.

    Is the Sonopet brand affected by this recall?

    Yes, Sonopet products are affected by this recall. This recall involves Sonopet Main Unit, Universal, and Universal Handpiece medical devices sold in Canada. They are being recalled because they should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids. Stop using the product for these procedures and follow the instructions from Health Canada.