The Recall Desk
ModerateFDA (Devices)·Z-2734-2014·Announced 2014-10-08

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).

What this means for you

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
Category
Medical Device — Therapeutic Device
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 (2)

  • All Lots
  • Series and Codes

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Related recalls

Same hazard · regulatory non compliance

See all →