Z-1423-2009

Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber...

Name: Z-1423-2009 Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber...
Creator: Sybaritic, Inc
Published: 2008-06-18
License: https://open.fda.gov/license/

Sybaritic, Inc. / initiated 2008-06-18 / Terminated / root cause: labeling and UDI

FDA source

Sybaritic, Inc began a recall of Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels on 2008-06-18. The reason FDA records is "Misbranded and sale without pre-market notification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1423-2009
Status: Terminated
Initiated: 2008-06-18
Posted: 2009-06-23
Terminated: 2012-07-06
Recalling firm: Sybaritic, Inc.
Product: Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels.
Product code: ISA Massager, Therapeutic, Electric
Reason for recall: Misbranded and sale without pre-market notification.
Root cause tag: labeling and UDI
FDA 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 in commerce: 1
Distribution: UT
Product codes and lots: Serial Number 2109257

Product code ISA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)