Z-0608-2010

Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner

Name: Z-0608-2010 Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner
Creator: Solafeet, Inc.
Published: 2009-09-08
License: https://open.fda.gov/license/

Solafeet, Inc. / initiated 2009-09-08 / Terminated / root cause: labeling and UDI

FDA source

Solafeet, Inc. began a recall of Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner on 2009-09-08. The reason FDA records is "Product failed to have a label that contained a recommended exposure schedule; the operator's manual provided inadequate instructions for use; and label implication may result in overexposure". 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-0608-2010
Status: Terminated
Initiated: 2009-09-08
Posted: 2010-02-16
Terminated: 2012-08-21
Recalling firm: Solafeet, Inc.
Product: Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner.
Product code: REG Suntan Lamp
Reason for recall: Product failed to have a label that contained a recommended exposure schedule; the operator's manual provided inadequate instructions for use; and label implication may result in overexposure.
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: Solafeet sent letters to customers informing them that the labeling and instructions included with the product were not in accordance with the FDA requirements. Attached with the letter was a replacement label and a replacement set of instructions. Customers are to attach the new label on top of the old label and use the new instructions, noting the change in exposure limits. Questions should be directed to 941-359-2608 or [email protected].
Quantity in commerce: 72 units
Distribution: Nationwide Distribution
Product codes and lots: Any codes associated with Model ST-400.

Product code REG

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)