Medical devicesUpdated Jan 3, 2026Smith & Nephew, Inc.Official source

    Tandem INTL Bipolar 46OD 28ID recall in Canada: reduced retention force

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    In plain language

    This recall involves the Tandem INTL Bipolar 46OD 28ID medical device sold in Canada. It's being recalled because an oversized retainer ring may reduce the retention force of the bipolar assembly. This recall is for healthcare professionals.

    What to do

    • Contact the manufacturer, Smith & Nephew, Inc., for additional information.

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    Affected products

    • Tandem INTL Bipolar 46OD 28ID

      Model: 71324046

      Lot: W2401399

    Why this matters

    Reduced retention force

    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: W2401399

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 71324046

    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?

    Reduced retention force

    What should consumers do?

    Contact the manufacturer, Smith & Nephew, Inc., for 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. Reduced retention force

    When was this product recalled?

    This product was recalled on October 30, 2024.

    Is the Smith & Nephew, Inc. brand affected by this recall?

    Yes, Smith & Nephew, Inc. products are affected by this recall. This recall involves the Tandem INTL Bipolar 46OD 28ID medical device sold in Canada. It's being recalled because an oversized retainer ring may reduce the retention force of the bipolar assembly. This recall is for healthcare professionals.