RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026neoBLUEOfficial source

    neoBLUE phototherapy systems recall in Canada: Inaccurate intensity measurements

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    In plain language

    This recall involves various neoBLUE LED phototherapy systems sold in Canada. They are being recalled because using the wrong radiometer can lead to inaccurate intensity measurements. Stop using the product and follow the instructions for updating the Instructions For Use.

    What to do

    • Stop using the product immediately.
    • Ensure the correct radiometer is used for intensity measurements.
    • Refer to the updated Instructions For Use for proper guidance.

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    Affected products

    • NEOBLUE MINI LED PHOTOTHERAPY SYSTEM

      Model: 010101

      Lot: Not applicable

    • NEOBLUE COZY LED PHOTOTHERAPY SYSTEM

      Model: 010121

      Lot: Not applicable

    • NEOBLUE LED THERAPY DEVICE

      Model: 010066, 010068, 010069, 010070

      Lot: Not applicable

    • NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM

      Model: 006244, 006898

      Lot: Not applicable

    • NEOBLUE COMPACT LED PHOTOTHERAPY SYSTEM

      Model: 019001, 019011

      Lot: Not applicable

    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: 006244, 006898, 010066, 010068, 010069, 010070, 010101, 010121, 019001, 019011

    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?

    This recall involves various neoBLUE LED phototherapy systems sold in Canada. They are being recalled because using the wrong radiometer can lead to inaccurate intensity measurements. Stop using the product and follow the instructions for updating the Instructions For Use.

    What should consumers do?

    Stop using the product immediately. Ensure the correct radiometer is used for intensity measurements. Refer to the updated Instructions For Use for proper guidance.

    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?

    A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.

    When was this product recalled?

    This product was recalled on May 1, 2018.

    Is the neoBLUE brand affected by this recall?

    Yes, neoBLUE products are affected by this recall. This recall involves various neoBLUE LED phototherapy systems sold in Canada. They are being recalled because using the wrong radiometer can lead to inaccurate intensity measurements. Stop using the product and follow the instructions for updating the Instructions For Use.