RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Smiths MedicalOfficial source

    Bivona Pediatric Tracheostomy Tube recall in Canada: labelling error

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    In plain language

    This recall involves the Bivona Pediatric Tracheostomy Tube sold in Canada. It's being recalled because of a labelling error on the unit box that incorrectly states the expiration date. This could cause delays in using the device if it's thought to be expired.

    What to do

    • Contact the manufacturer, Smiths Medical, if you need more information.

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    Affected products

    • Bivona Pediatric Tracheostomy Tube

      Model: 60P045

      Lot: 4125816

    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: 4125816

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 60P045

    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 the Bivona Pediatric Tracheostomy Tube sold in Canada. It's being recalled because of a labelling error on the unit box that incorrectly states the expiration date. This could cause delays in using the device if it's thought to be expired.

    What should consumers do?

    Contact the manufacturer, Smiths Medical, if you need more 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 August 31, 2023.

    Is the Smiths Medical brand affected by this recall?

    Yes, Smiths Medical products are affected by this recall. This recall involves the Bivona Pediatric Tracheostomy Tube sold in Canada. It's being recalled because of a labelling error on the unit box that incorrectly states the expiration date. This could cause delays in using the device if it's thought to be expired.