Device recall

Z-1541-2015: Portable FAR Infrared Sauna Indications including, but not limited to Natural…

FDA device recall · Class II · Therasage, LLC.

Key facts

Recall number (Z-number) Z-1541-2015
Recall event 70737
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 .
Recalling firm Therasage, LLC.
Recall class Class II
Status Terminated
Termination date Aug 6, 2015
FEI number 3005893178

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)