The Recall Desk

FDA (Devices) recall action 70737

Therasage, LLC. recalled 3 products on 2015-05-06

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2015-05-06
Critical
0
Units
8

Why these products were recalled

Product distributed without 510(k) approval

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2015-05-06

    Therasage FAR-Infrared Heat Home Sauna Recalled for Lack of FDA Approval

    Therasage, LLC. is recalling FAR-Infrared Heat Home Saunas because they were distributed without FDA 510(k) approval.

    Product
    FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2015-05-06

    Therasage FAR-Infrared Heat Home Sauna Recalled for Lack of FDA Approval

    Therasage, LLC. is recalling its FAR-Infrared Heat Home Sauna because the product was distributed without the required FDA 510(k) approval.

    Product
    FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2015-05-06

    Therasage Portable FAR Infrared Sauna Recalled for Lack of FDA Approval

    Therasage, LLC. is recalling 8 portable FAR infrared saunas because they were distributed without FDA 510(k) approval.

    Product
    Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
    Category
    Distribution
    8 states