FAR-Infrared Heat Home Sauna — Class II medical device recall Z-1540-2015
Terminated recall by Therasage, LLC., reported 2015-05-06, distributed nationwide. Product distributed without 510(k) approval
| Recall number | Z-1540-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Therasage, LLC., Boca Raton, FL, United States |
| Recall initiated | 2014-12-23 |
| Classified | 2015-04-28 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 0 |
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 .
Reason for recall
Product distributed without 510(k) approval
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1540-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.