Baro-Therapies Rejuvenator Chamber Recalled for Lack of FDA Approval
Baro-Therapies, Inc. is recalling 10 Rejuvenator Chambers because they were distributed without an approved 510(k).
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is regulatory non-compliance rather than a direct physical defect causing harm.
Plain-English summary
Baro-Therapies, Inc. is recalling 10 units of the Rejuvenator Chamber. The device is indicated for relief from general aches and pains brought on by changes in the weather.
The recall was initiated because the firm distributed the device without an approved 510(k) clearance from the FDA. The agency has classified this recall as Class II.
The affected units were distributed nationwide in the states of Florida, Georgia, Mississippi, Tennessee, and Colorado. All lots, series, and codes are included in this recall. Consumers should stop using the device and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather.
- Manufacturer
- Baro-Therapies, Inc
- 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 (2)
- All Lots
- Series and Codes
Distribution
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