RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026AutolithOfficial source

    Autolith Lithotripter System - Probes recall in Canada: Biocompatibility issue

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    In plain language

    This recall involves Autolith Lithotripter System - Probes sold in Canada. They are being recalled because a lot failed biocompatibility testing. 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

    • Autolith Lithotripter System - Probes

      Model: 9-195-371DS

      Lot: NK12511, NK12801

    Why this matters

    Biocompatibility issue

    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: NK12511, NK12801

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 9-195-371DS

    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?

    Biocompatibility issue

    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. Biocompatibility issue

    When was this product recalled?

    This product was recalled on April 17, 2020.

    Is the Autolith brand affected by this recall?

    Yes, Autolith products are affected by this recall. This recall involves Autolith Lithotripter System - Probes sold in Canada. They are being recalled because a lot failed biocompatibility testing. Stop using the product and follow the return steps in the official notice.