RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026PneumoSureOfficial source

    PneumoSure High Flow Insufflator tube sets recall in Canada: Detachment risk

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    In plain language

    This recall involves PneumoSure High Flow Insufflator High Flow II Tube Sets and Heated Tube Sets with RTP sold in Canada. They are being recalled because the tube set can detach from the cassette. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Contact Stryker Endoscopy for more information.
    • Follow the manufacturer's instructions for return or replacement.

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    Affected products

    • PneumoSure High Flow Insufflator - High Flow II Tube Set

      Model: 620040660

      Lot: More than 10 numbers, contact manufacturer.

    • PneumoSure High Flow Insufflator - Heated Tube Set with RTP

      Model: 0620-040-690, 620-040-680

      Lot: More than 10 numbers, contact manufacturer.

    Why this matters

    Detachment risk

    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: 0620-040-690, 620-040-680, 620040660

    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?

    Detachment risk

    What should consumers do?

    Stop using the product immediately. Contact Stryker Endoscopy for more information. Follow the manufacturer's instructions for return or replacement.

    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. Detachment risk

    When was this product recalled?

    This product was recalled on March 28, 2019.

    Is the PneumoSure brand affected by this recall?

    Yes, PneumoSure products are affected by this recall. This recall involves PneumoSure High Flow Insufflator High Flow II Tube Sets and Heated Tube Sets with RTP sold in Canada. They are being recalled because the tube set can detach from the cassette. Stop using the product and follow the return steps in the official notice.