Therasage, LLC.: Medical Device Recall in 2015 - (Recall #: Z-1539-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 23, 2014

Date Posted: May 6, 2015

Recall Number: Z-1539-2015

Event ID: 70737

Reason for Recall:

Product distributed without 510(k) approval

Status: Terminated

Product Quantity: 0

Code Information:

TS4544

Distribution Pattern:

Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.

Voluntary or Mandated:

Voluntary: Firm initiated