FDA recall Z-2734-2018

Water Pik, Inc. · Class II · device

Product

Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

Reason for recall

Charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns.

Distribution

U.S. Nationwide Distribution in the states of TX, KY, WA, NY, VA, CA, NC, IA, MA, OR, OH, GA, NV, CT, IL, SC, PA, MD, IN, WV, ND, MS, CO, AZ, WI, KS, FL, HI, OK, VT, MO, ID, RI, MN, MI, AR, LA, TN, DC, NJ, NH, NE, AL, UT, ME, NM, AK, DE, SD, MT, WY and country of Canada

Key facts

Status
Terminated
Initiation date
2018-07-02
Report date
2018-08-15
Termination date
2022-05-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fort Collins, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2734-2018