FDA Medical Device Recalls (openFDA)
Sybaritic, Inc: Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels.
- Recall number
- Z-1423-2009
- Recalling firm
- Sybaritic, Inc
- Product
- Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels.
- Status
- Terminated
- Initiated
- 2008-06-18
- Posted
- 2009-06-23
- Terminated
- 2012-07-06
- Reason
- Misbranded and sale without pre-market notification.
- Root cause
- PMA
- Action
- Sybaritic sent a letter to the consignee on June 18, 2008. The letter confirmed their phone conversation on June 16 regarding the required Field Correction of the device. The letter also described the changes to be performed by the local technician to be in compliance with the FDA.
- Quantity
- 1
- Distribution
- UT
- Lot, serial or model codes
- Serial Number 2109257
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ISA
- Firm FEI
- 2131125
- Firm city
- Bloomington
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28