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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a regulatory compliance issue (lack of 510(k) approval) rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Therasage, LLC. is recalling its FAR-Infrared Heat Home Sauna, a 2-person model. The recall was initiated because the product was distributed without 510(k) approval, which is required by the U.S. Food and Drug Administration for medical devices.
The affected units were distributed nationwide, including in South Dakota, Illinois, Texas, Oregon, New York, Wisconsin, Georgia, and California. The product code associated with the recall is TS4544.
Consumers who possess this product should stop using it and contact Therasage, LLC. for further instructions regarding the recall.
The recalled product
- 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 .
- Manufacturer
- Therasage, LLC.
- Category
- Medical Device — Home Sauna
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- TS4544
Distribution
Part of a larger recall action
This product is one of 3 recalled by Therasage, LLC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Therasage, LLC.
See all →- ModerateTherasage FAR-Infrared Heat Home Sauna Recalled for Lack of FDA Approval
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FDA (Devices) · 2015-05-06
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