RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026MedallionOfficial source

    1 mL Medallion Syringe recall in Canada: manufacturing defect

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    In plain language

    This recall involves specific lots of 1 mL Medallion Syringes sold in Canada. They are being recalled due to a manufacturing defect with the syringe plunger tip. This defect may cause air to enter the barrel or fluid to leak out.

    What to do

    • Stop using the product immediately.
    • Contact Merit Medical Systems, Inc. for more information.
    • Follow the manufacturer's instructions for return or disposal.

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    Affected products

    • 1 mL Medallion Syringe

      Model: K01-05526P, K01-07427, K01-07477P, K01-07930P, K02-00565C, K02-01260B, K02-01331A, K04-00748, K12-03636, MSS011, MSS011-DG, MSS011-LG, MSS011-PR, MSS011-R, MSS011-Y, MSS011-YP

      Lot: More than 10 numbers, contact manufacturer.

    Why this matters

    Potential for air to enter or fluid to leak from syringe

    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: K01-05526P, K01-07427, K01-07477P, K01-07930P, K02-00565C, K02-01260B, K02-01331A, K04-00748, K12-03636, MSS011, MSS011-DG, MSS011-LG, MSS011-PR, MSS011-R, MSS011-Y, MSS011-YP

    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?

    Potential for air to enter or fluid to leak from syringe

    What should consumers do?

    Stop using the product immediately. Contact Merit Medical Systems, Inc. for more information. Follow the manufacturer's instructions for return or disposal.

    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. Potential for air to enter or fluid to leak from syringe

    When was this product recalled?

    This product was recalled on March 23, 2018.

    Is the Medallion brand affected by this recall?

    Yes, Medallion products are affected by this recall. This recall involves specific lots of 1 mL Medallion Syringes sold in Canada. They are being recalled due to a manufacturing defect with the syringe plunger tip. This defect may cause air to enter the barrel or fluid to leak out.