Z-0182-2008

Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle...

Name: Z-0182-2008 Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle...
Creator: Pacific Bioscience Lab, Inc.
Published: 2007-07-03
License: https://open.fda.gov/license/

Pacific Bioscience Lab, Inc. / initiated 2007-07-03 / Terminated / root cause: design

FDA source

Pacific Bioscience Lab, Inc. began a recall of Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Pacific Bioscience... on 2007-07-03. The reason FDA records is "Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0182-2008
Status: Terminated
Initiated: 2007-07-03
Posted: 2007-11-16
Terminated: 2010-12-13
Recalling firm: Pacific Bioscience Lab, Inc.
Product: Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Pacific Bioscience Laboratories, Inc., 13222 SE 30th St., Bellevue, WA 98005
Product code: FLG Cleaner, Ultrasonic, Medical Instrument
Reason for recall: Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.
Root cause tag: design
FDA root cause: Device Design
Action: On August 30, 2007, the firm issued a press statement via PR Newswire and The Associated Press. They also posted a Recall Notice on their website (www.Clarisonic.com) requesting consumers to return their affected products for an exchange. All retailers and professional resellers were notified by telephone, E mail and/or letter and asked to return unsold inventory, as well as, post the provided point of sales notices and send provided post cards to known customers requesting exchange of recalled product. All users can contact the firm via the website or by phone at 1-866-378-7360 (6 am-6pm, M-F, Pacific Time) to arrange for the device exchange.
Quantity in commerce: 97,500
Distribution: Worldwide Distribution - including USA and countries of Japan and Canada. Units were distributed to retailers and professional skin care clinics throughout the USA. In addition, units were distributed to one distributor in Japan and to 4 clinics in Canada.
Product codes and lots: All codes prior to 07177xx. (June 26, 2007). Lot codes are as follows: YYDDDxx, where DDD is the ordinal date. Handle codes are clearly printed on the bottom of the handle. All codes lot codes after, and including 07177xx are not subject to recall, and are followed by a "T" or "J" for ease in identification

Product code FLG

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)