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Terminated

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.

FDA Recall Z-2734-2018 · Posted None

Recalling FirmWater Pik, Inc.
Recall StatusTerminated
Product CodeJET
Date Initiated2018-07-02
Date Terminated2022-05-24
Product Quantity3797

Reason for Recall

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

Firm Action

On 07/02/2018, the firm sent customers an Urgent Medical Device Recall notice. Customers were instructed to stop using affected devices, immediately unplug the units, and to return these devices using firm-provided prepaid return labels. For questions, consumers should call 1-800-674-7718 from 7:00 a.m. to 5:00 p.m. MDT, Monday through Friday. On 07/05/2018, Urgent Medical Device Recall notices were mailed to all customers via overnight mail. On 07/13/2018, the firm issued a press release, which also stated to call 1-800-674-7718 to receive a product return kit. Customers were encouraged to report adverse events to MedWatch via http://www.fda.gov/MedWatch/report.htm (online), http://www.fda.gov/MedWatch/getforms.htm (mail), 1-800-332-1088 (phone), or 1-800-FDA-0178 (fax).

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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