RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Olea MedicalOfficial source

    Olea Sphere V3.0 recall in Canada: potential for inaccurate medical results

    Share:

    In plain language

    This recall involves the Olea Sphere V3.0 medical device sold in Canada. It's being recalled because certain types of acquisitions could lead to errors in quantitative parameter estimations. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Follow the return or repair instructions from the manufacturer.

    Get alerts for recalls like this

    Get email alerts when new recalls affect products in this category.

    Categories (optional)

    No spam. Unsubscribe anytime. We only email when there's a relevant recall.

    Affected products

    • Olea Sphere V3.0

      Model: OLMV3.0

      Lot: Not applicable.

    Why this matters

    Potential for inaccurate medical results

    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: Not applicable.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: OLMV3.0

    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.

    Want alerts if similar products are recalled in Canada?

    Frequently Asked Questions

    Why was this product recalled?

    Potential for inaccurate medical results

    What should consumers do?

    Stop using the product immediately. Follow the return or repair instructions from the manufacturer.

    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 inaccurate medical results

    When was this product recalled?

    This product was recalled on May 10, 2019.

    Is the Olea Medical brand affected by this recall?

    Yes, Olea Medical products are affected by this recall. This recall involves the Olea Sphere V3.0 medical device sold in Canada. It's being recalled because certain types of acquisitions could lead to errors in quantitative parameter estimations. Stop using the product and follow the return steps in the official notice.