Medical devicesUpdated Jan 3, 2026Lutronic CorporationOfficial source

    Clarity II Main System Body recall in Canada: May cause patient injury

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    In plain language

    This recall involves the Clarity II Main System Body, a medical device sold in Canada. It's being recalled because a software bug may prevent the 'skin temp' feature from updating, which could increase the probability of patient injury or burns. Customers will be contacted by the manufacturer regarding this issue.

    What to do

    • Customers will be contacted by the manufacturer.
    • Follow the instructions provided by the manufacturer.

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    Affected products

    • Clarity II Main System Body

      Model: Not applicable.

    Why this matters

    May increase the probability of patient injury or burn

    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 model number

      Model numbers are typically on the product label or packaging.

      Affected models: Not applicable.

    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?

    May increase the probability of patient injury or burn

    What should consumers do?

    Customers will be contacted by the manufacturer. Follow the instructions provided by the manufacturer.

    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. May increase the probability of patient injury or burn

    When was this product recalled?

    This product was recalled on January 29, 2025.

    Is the Lutronic Corporation brand affected by this recall?

    Yes, Lutronic Corporation products are affected by this recall. This recall involves the Clarity II Main System Body, a medical device sold in Canada. It's being recalled because a software bug may prevent the 'skin temp' feature from updating, which could increase the probability of patient injury or burns. Customers will be contacted by the manufacturer regarding this issue.