Medical device recalls Moderate risk

Waterpik Sonic-Fusion Professional recalled over fire hazard

Recall date
July 2, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Water Pik, Inc. recalls Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrig…
Recall number
Z-2734-2018
FDA classification
Class II
Brand / firm
Water Pik, Inc.
Sold / distributed
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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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