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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Manufacturer
- Life Force of Tampa, LLC
- Hazard
- 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
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