RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Official source

    Heater Unit HU 35 recall in Canada: incorrect software

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    In plain language

    This recall involves the Heater Unit HU 35 sold in Canada. It's being recalled because it may have incorrect software, which could lead to unintended hypothermia in patients. Stop using the product and follow the return/repair steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the model and serial numbers.
    • Contact Maquet Cardiopulmonary GmbH for instructions.

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    Affected products

    • Heater Unit HU 35

      Model: 70107.2163

      Lot: 90034520, 90034521, 90034536, 90034537, 90034539

    Why this matters

    Risk of unintended hypothermia

    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: 90034520, 90034521, 90034536, 90034537, 90034539

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 70107.2163

    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?

    Risk of unintended hypothermia

    What should consumers do?

    Stop using the product immediately. Check the model and serial numbers. Contact Maquet Cardiopulmonary GmbH for instructions.

    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. Risk of unintended hypothermia

    When was this product recalled?

    This product was recalled on August 16, 2019.