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    Medical devicesUpdated Jan 3, 2026OrigenOfficial source

    Origen O-Wrap System recall in Canada: Unsealed sterile barrier

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    In plain language

    This recall involves the Origen O-Wrap System, TissueVault Tissue Freezing Bags, and DMSO-Resistant Bag Spike With Needle-Free Injection Port sold in Canada. They are being recalled because the sterile barrier pouch may be unsealed. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the lot or model numbers provided.
    • Contact Origen Biomedical Inc. for return instructions.

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    Affected products

    • Origen O-Wrap System

      Model: OW1430

      Lot: U20630

    • TissueVault Tissue Freezing Bags

      Model: TV0918

      Lot: U20592

    • DMSO-Resistant Bag Spike With Needle-Free Injection Port

      Model: CBS

      Lot: U20617, U20683, U20711, U20725

    Why this matters

    Compromised sterility

    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: U20592, U20617, U20683, U20711, U20725, U20630

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: CBS, OW1430, TV0918

    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?

    Compromised sterility

    What should consumers do?

    Stop using the product immediately. Check the lot or model numbers provided. Contact Origen Biomedical Inc. for return instructions.

    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. Compromised sterility

    When was this product recalled?

    This product was recalled on December 13, 2019.

    Is the Origen brand affected by this recall?

    Yes, Origen products are affected by this recall. This recall involves the Origen O-Wrap System, TissueVault Tissue Freezing Bags, and DMSO-Resistant Bag Spike With Needle-Free Injection Port sold in Canada. They are being recalled because the sterile barrier pouch may be unsealed. Stop using the product and follow the return steps in the official notice.