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    Medical devicesUpdated Jan 3, 2026BivonaOfficial source

    Bivona Aire Cuff Wireless Endotracheal Tubes recall in Canada: Sterility risk

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    In plain language

    This recall involves Bivona Aire Cuff Wireless Endotracheal Tubes sold in Canada. They are being recalled because the packaging seal may be compromised, which could affect product sterility. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check model numbers 25W080, 25W085, 25W090, 35W080, 35W085, 35W090, 35W095.
    • Contact Smiths Medical for return instructions.

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    Affected products

    • Bivona Aire Cuff Wireless Endotracheal Tubes

      Model: 25W080, 25W085, 25W090, 35W080, 35W085, 35W090, 35W095

      Lot: More than 10 numbers, contact manufacturer.

    Why this matters

    Compromised sterility

    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: 25W080, 25W085, 25W090, 35W080, 35W085, 35W090, 35W095

    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?

    Compromised sterility

    What should consumers do?

    Stop using the product immediately. Check model numbers 25W080, 25W085, 25W090, 35W080, 35W085, 35W090, 35W095. Contact Smiths Medical for return 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. Compromised sterility

    When was this product recalled?

    This product was recalled on August 19, 2021.

    Is the Bivona brand affected by this recall?

    Yes, Bivona products are affected by this recall. This recall involves Bivona Aire Cuff Wireless Endotracheal Tubes sold in Canada. They are being recalled because the packaging seal may be compromised, which could affect product sterility. Stop using the product and follow the return steps in the official notice.