Medical devicesUpdated Jan 3, 2026Gambro Lundia ABOfficial source

    AK 96 and AK 98 Dialysis Machines recall in Canada: Hemolysis risk

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    In plain language

    This recall involves AK 96 and AK 98 Dialysis Machines sold in Canada. They are being recalled because a part of the machine could cause hemolysis. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Contact the manufacturer for additional information.

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    Affected products

    • AK 98, 115V, Self-Care

      Model: 115251

      Lot: All lots

    • AK 98 V2 115v Bio Self-Care

      Model: 955407

      Lot: All lots

    • AK 96, 115 V, Self-Care

      Model: 110661

      Lot: All lots

    • AK 98v3 115v Self-Care

      Model: 955606

      Lot: All lots

    • AK 96, 115 V, Bio

      Model: 110373

      Lot: 20072, 19489

    Why this matters

    Hemolysis 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: 20072, 19489, All lots

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 110373, 110661, 115251, 955407, 955606

    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?

    Hemolysis risk

    What should consumers do?

    Stop using the product immediately. Contact the manufacturer for additional information.

    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. Hemolysis risk

    When was this product recalled?

    This product was recalled on January 17, 2025.

    Is the Gambro Lundia AB brand affected by this recall?

    Yes, Gambro Lundia AB products are affected by this recall. This recall involves AK 96 and AK 98 Dialysis Machines sold in Canada. They are being recalled because a part of the machine could cause hemolysis. Stop using the product and contact the manufacturer for more information.