FDAClass IIMay 6, 2015

FAR-Infrared Heat Home Sauna recall

FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer…

Why was FAR-Infrared Heat Home Sauna recalled?

Product distributed without 510(k) approval

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

TS4544

Product
FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer…
Recalling firm
Therasage, LLC.
Quantity
0
Distribution
Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.
Recall date
May 6, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls