Medical devicesUpdated Jan 3, 2026Terumo Bct, Inc.Official source

    COBE 2991 Disposable Sets recall in Canada: Performance issues

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    In plain language

    This recall involves COBE 2991 Disposable Sets sold in Canada. They are being recalled because of performance issues that may lead to leaks or loss of product. Stop using the product and follow the return/repair steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Contact the manufacturer for instructions on how to mitigate risk.
    • Do not use affected devices.

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    Affected products

    • COBE 2991 Blood Processing Set

      Model: 90819

      Lot: More than 10 numbers, contact manufacturer.

    • Triple Processing Set

      Model: 02G15222, 07G15207, 10G15203, 90901

    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: More than 10 numbers, contact manufacturer.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 02G15222, 07G15207, 10G15203, 90819, 90901

    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 COBE 2991 Disposable Sets sold in Canada. They are being recalled because of performance issues that may lead to leaks or loss of product. Stop using the product and follow the return/repair steps in the official notice.

    What should consumers do?

    Stop using the product immediately. Contact the manufacturer for instructions on how to mitigate risk. Do not use affected devices.

    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 November 13, 2024.

    Is the Terumo Bct, Inc. brand affected by this recall?

    Yes, Terumo Bct, Inc. products are affected by this recall. This recall involves COBE 2991 Disposable Sets sold in Canada. They are being recalled because of performance issues that may lead to leaks or loss of product. Stop using the product and follow the return/repair steps in the official notice.