The Recall Desk
HighFDA (Devices)·Z-2625-2014·Announced 2014-09-17

Life Force Chamber Recalled for Lack of FDA Approval

Life Force of Tampa, LLC is recalling 10 Life Force Chambers because the product is marketed as a medical device without FDA premarket approval.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a product marketed as a medical device without FDA approval, representing a risk-of-harm product where injury has not yet been reported, consistent with the High severity criteria.

Plain-English summary

Life Force of Tampa, LLC is recalling 10 units of the Life Force Chamber. The product is marketed and promoted as a medical device intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

The recall was initiated because Life Force of Tampa does not have an approved application for premarket approval in effect, nor an approved application for an investigational device exemption. The source text does not report any specific illnesses, injuries, or deaths associated with the use of these devices.

The recalled units were distributed nationwide in Arizona, Florida, Maryland, Nevada, Oklahoma, Pennsylvania, and Texas. Consumers who possess a Life Force Chamber should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
Affected units
10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • ALL Life Force Chambers

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically: