FDA Medical Device Recalls (openFDA)
Therasage, LLC.: Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
- Recall number
- Z-1541-2015
- Recalling firm
- Therasage, LLC.
- Product
- Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
- Status
- Terminated
- Initiated
- 2014-12-23
- Posted
- 2015-04-28
- Terminated
- 2015-08-06
- Reason
- Product distributed without 510(k) approval
- 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 info@therasage.com. For questions regarding this recall call 561-416-9300.
- Quantity
- 8 devices
- Distribution
- Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.
- Lot, serial or model codes
- PS2002
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3005893178
- Firm city
- Boca Raton
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28