RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Gambro Renal Products Inc.Official source

    Revaclear Dialyzers recall in Canada: Performance issues

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    In plain language

    This recall involves Revaclear 400 and Revaclear 300 Dialyzers sold in Canada. They are being recalled due to performance issues, including internal blood leaks and polyurethane displacement. Contact the manufacturer for more information.

    What to do

    • Contact the manufacturer for additional information.

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    Affected products

    Specific affected products are listed in the official notice.

    Do I have this product?

    This recall applies to specific products. Details are listed in the official notice.

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    Frequently Asked Questions

    Why was this product recalled?

    This recall involves Revaclear 400 and Revaclear 300 Dialyzers sold in Canada. They are being recalled due to performance issues, including internal blood leaks and polyurethane displacement. Contact the manufacturer for more information.

    What should consumers do?

    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?

    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 December 2, 2022.

    Is the Gambro Renal Products Inc. brand affected by this recall?

    Yes, Gambro Renal Products Inc. products are affected by this recall. This recall involves Revaclear 400 and Revaclear 300 Dialyzers sold in Canada. They are being recalled due to performance issues, including internal blood leaks and polyurethane displacement. Contact the manufacturer for more information.