FDA Device recall Z-1540-2015
FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health,…
- FDA Device
- Class II
- terminated
- Published 2015-05-06
On 2015-05-06 the FDA classified a Class II recall of FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health,… by Therasage, citing product distributed without 510(k) approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1540-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-23 |
| Published | 2015-05-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Therasage |
| Distribution | US |
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
Product distributed without 510(k) approval
Identifiers
| code_info | TS5651 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1540-2015%22
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