CLASS II Device recall · Reported 6 May 2015 · FDA Enforcement Report

Portable FAR Infrared Sauna recalled by Therasage

Therasage is recalling Portable FAR Infrared Sauna, distributed nationwide in the US. The recall was initiated on 23 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPS2002

Quantity recalled8 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1541-2015
FDA event ID: 70737
Recalling firm: Therasage, Boca Raton, FL
Classification: Class II
Status: Terminated
Recall initiated: 23 Dec 2014
FDA classified: 28 Apr 2015
Reported: 6 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Dec 2014	Recall initiated by company
28 Apr 2015	Classified by FDA	+126 days
6 May 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product distributed without 510(k) approval

Product as listed by the FDA

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 .

Where it was distributed

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

Nationwide California Georgia Illinois New York Oregon South Dakota Texas Wisconsin

Questions about this recall

Is Portable FAR Infrared Sauna recalled?

Yes. Therasage recalled Portable FAR Infrared Sauna on 23 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-1541-2015.

Why was it recalled?

Product distributed without 510(k) approval

Which lots are affected?

PS2002

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Therasage

All 3

Reported	Class	Recall	Company	Reason	Where
6 May 2015Device	CLASS II	FAR-Infrared Heat Home Sauna, 2 person recalled by Therasage	Therasage	Other	Nationwide
6 May 2015Device	CLASS II	FAR-Infrared Heat Home Sauna, 3 person recalled by Therasage	Therasage	Other	Nationwide

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