Medical devicesUpdated Jan 3, 2026Coloplast A/SOfficial source

    Coloplast Catheters recall in Canada: sterility issue

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    In plain language

    This recall involves Coloplast Prostatic Catheters and Folysil Catheters sold in Canada. They are being recalled because the packaging may have holes, which could affect sterility. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Contact the manufacturer if you require additional information.

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    Affected products

    • Prostatic Catheters

      Lot: XB6322, XB6L22, XB6L24, AB6G20, AB6020, AB6320, AB6A18, AB6A22, AB6C24, AB6G24, AB6324, AB6G18, AB6H22, AB6520, AB6B24, AB6C18, AB6C22, AB6A20, AB6220, AB6318, AB6A24, AB6018, AB6022, AB6224, AB6322, AB6120, AB6122, AB6222, AB6518, AB6C20, AB6G22, AB6H18, AB6H24

    • Folysil Catheters

      Lot: AA6316, AA6314, AA6310, AA6322, AA6324, AA6308, AA6318, AA6320, AA6312, AA6120, AA6412, AA6420, AA6110, AA6114, AA6124, AA6406, AA6C22, AA6106, AA6410, AA6514, AA6516, AA6408, AA6512, AA6112, AA6118, AA6418, AA6422, AA6C20, AA6108, AA6122, AA6414, AA6116, AA6416, AA6522, AA6C18, AA6C24

    Why this matters

    Sterility issue due to packaging defect

    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: AA6316, AA6314, AA6310, AA6322, AA6324, AA6308, AA6318, AA6320, AA6312, AA6120, AA6412, AA6420, AA6110, AA6114, AA6124, AA6406, AA6C22, AA6106, AA6410, AA6514, AA6516, AA6408, AA6512, AA6112, AA6118, AA6418, AA6422, AA6C20, AA6108, AA6122, AA6414, AA6116, AA6416, AA6522, AA6C18, AA6C24, XB6322, XB6L22, XB6L24, AB6G20, AB6020, AB6320, AB6A18, AB6A22, AB6C24, AB6G24, AB6324, AB6G18, AB6H22, AB6520, AB6B24, AB6C18, AB6C22, AB6A20, AB6220, AB6318, AB6A24, AB6018, AB6022, AB6224, AB6322, AB6120, AB6122, AB6222, AB6518, AB6C20, AB6G22, AB6H18, AB6H24

    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?

    Sterility issue due to packaging defect

    What should consumers do?

    Stop using the product immediately. Contact the manufacturer if you require 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. Sterility issue due to packaging defect

    When was this product recalled?

    This product was recalled on December 30, 2024.

    Is the Coloplast A/S brand affected by this recall?

    Yes, Coloplast A/S products are affected by this recall. This recall involves Coloplast Prostatic Catheters and Folysil Catheters sold in Canada. They are being recalled because the packaging may have holes, which could affect sterility. Stop using the product and contact the manufacturer for more information.