The Rejuvenator Chamber manufactured by Baro-Therapies — Class II medical device recall Z-2734-2014
Terminated recall by Baro-Therapies, Inc, reported 2014-10-08, distributed nationwide. The firm is distributing the Rejuvenator device without an approved 510(k).
| Recall number | Z-2734-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baro-Therapies, Inc, Miramar Beach, FL, United States |
| Recall initiated | 2014-08-08 |
| Classified | 2014-09-30 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2015-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 10 |
| Reason classes | unapproved 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.
Reason for recall
The firm is distributing the Rejuvenator device without an approved 510(k).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2734-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.