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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Therasage, LLC. is recalling the FAR-Infrared Heat Home Sauna, 3 person, because the product was distributed without FDA 510(k) approval. The recall number is Z-1540-2015.
The product was distributed nationwide, including in South Dakota, Illinois, Texas, Oregon, New York, Wisconsin, Georgia, and California. The specific code for the affected units is TS5651.
Consumers should stop using the product and contact Therasage, LLC. for further instructions.
The recalled product
- 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 .
- Manufacturer
- Therasage, LLC.
- Category
- Medical Device — Home Sauna
- Hazard
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)
- TS5651
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
FDA (Devices) · 2015-05-06
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FDA (Devices) · 2015-05-06
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