RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026PreludeSYNCOfficial source

    PreludeSYNC recall in Canada: Device may not maintain compression

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    In plain language

    This recall involves the PreludeSYNC Distal Radial Compression Device sold in Canada. It's being recalled because the inflatable balloons may break or burst, which could lead to air leakage and the inability to maintain pressure. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check model and lot numbers.
    • Return the product as instructed.

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    Affected products

    • PreludeSYNC Distal Radial Compression Device

      Model: SDRB-REG-LT, SDRB-REG-RT

      Lot: H1559517, H1666548

    Why this matters

    Device may not maintain pressure/compression

    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: H1559517, H1666548

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: SDRB-REG-LT, SDRB-REG-RT

    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.

    Want alerts if similar products are recalled in Canada?

    Frequently Asked Questions

    Why was this product recalled?

    Device may not maintain pressure/compression

    What should consumers do?

    Stop using the product immediately. Check model and lot numbers. Return the product as instructed.

    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. Device may not maintain pressure/compression

    When was this product recalled?

    This product was recalled on April 17, 2020.

    Is the PreludeSYNC brand affected by this recall?

    Yes, PreludeSYNC products are affected by this recall. This recall involves the PreludeSYNC Distal Radial Compression Device sold in Canada. It's being recalled because the inflatable balloons may break or burst, which could lead to air leakage and the inability to maintain pressure. Stop using the product and follow the return steps in the official notice.