RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026BivonaOfficial source

    Bivona Tracheostomy Products recall in Canada: performance issue

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    In plain language

    This recall involves Bivona Neonatal/Pediatric and Adult Tracheostomy Products sold in Canada. They are being recalled because a manufacturing defect may cause the securement flange to tear. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Contact Smiths Medical Asd, Inc. for additional information.

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    Affected products

    Specific affected products are listed in the official notice.

    Why this matters

    Performance issue due to manufacturing defect

    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?

    Performance issue due to manufacturing defect

    What should consumers do?

    Stop using the product immediately. Contact Smiths Medical Asd, Inc. 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. Performance issue due to manufacturing defect

    When was this product recalled?

    This product was recalled on June 3, 2024.

    Is the Bivona brand affected by this recall?

    Yes, Bivona products are affected by this recall. This recall involves Bivona Neonatal/Pediatric and Adult Tracheostomy Products sold in Canada. They are being recalled because a manufacturing defect may cause the securement flange to tear. Stop using the product and contact the manufacturer for more information.