Water Pik, Inc. Recalls Sonic-Fusion® Flossing Toothbrush Product for Possible Health Risk
- Company Announcement Date:
- July 12, 2018
- FDA Publish Date:
- May 23, 2019
- Product Type:
- Medical Devices
- Reason for Announcement:
- Company Name:
- Water Pik, Inc
- Brand Name:
- Product Description:
Product DescriptionFlossing toothbrush
Water Pik, Inc. is voluntarily recalling its Sonic-Fusion® flossing toothbrush because the charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns. Water Pik, Inc. has received consumer reports of product malfunctioning in the U.S.
The recall is applicable only to Sonic-Fusion® products. All other Waterpik® brand flossers and toothbrushes are not affected.
The following models have been recalled:
|Name of Product||Model||Serial/Lot Numbers|
|Sonic-Fusion®||SF-01||SF01 17 06 01 through SF01 18 06 28|
|Sonic-Fusion®||SF-02||SF02 17 06 01 through SF02 18 06 28|
The total quantity is 3,800 units.
The indicated lots were distributed between June 2017 and June 2018 in all U.S. states and in Canada and limited to professional educators, key opinion leaders, trade show customers and limited direct online sales.
Consumers who have the affected units should stop using them, immediately unplug the unit, and return them to Water Pik, Inc.
To receive a product return kit, or for additional information, consumers should call 1-800-674-7718 from 7:00 a.m. to 5:00 p.m. MDT, Monday through Friday or email at SonicFusion-Return@Waterpik.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
For additional information go to SFReturn.com
Company Contact Information
- Teresa Ricketts