Z-1539-2015Class II

FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief...

Name: Z-1539-2015 FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief...
Creator: Therasage, LLC.
Published: 2014-12-23
License: https://open.fda.gov/license/

Therasage Corporation / initiated 2014-12-23 / Terminated / root cause: labeling and UDI

FDA source

Therasage, LLC. began a recall of FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme... on 2014-12-23. FDA classified it as Class II and gives the reason as "Product distributed without 510(k) approval". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1539-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-23
Posted: 2015-04-28
Terminated: 2015-08-06
Recalling firm: Therasage Corporation
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 .
Product code: N/A
Reason for recall: Product distributed without 510(k) approval
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: On January 20, 2015 Therasage sent a notification to its consignees asking them to discard any of the labeling materials that state the following: 1) Use of the sauna allows one to "naturally detoxify." 2) Use of the sauna expels toxins from the body 3) Any reference to an exact amount of calories one uses in an hour when enjoying the benefits of this product 4) Although this product is enhanced with a negative ion environment, we cannot say that the product is enhanced with negative ion therapy 5) Any reference to the maximum infrared absorption available cannot be explicitly stated, as it may vary for each individual person. Customers with questions were instructed to call 888-416-4441 or email [email protected]. For questions regarding this recall call 561-416-9300.
Quantity in commerce: 0
Distribution: Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.
Product codes and lots: TS4544

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1539-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1539-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-28
Z-1540-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-28
Z-1541-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-28

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)