FDA Medical Device Recalls (openFDA)
Water Pik, Inc.: 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.
- Recall number
- Z-2734-2018
- Recalling firm
- Water Pik, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2018-07-02
- Posted
- not on file
- Terminated
- 2022-05-24
- Reason
- Charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns.
- Root cause
- Under Investigation by 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).
- Quantity
- 3797
- 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
- Lot, serial or model codes
- Serial #: SF02 17 06 01 through SF02 18 06 28
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JET
- Firm FEI
- 1712259
- Firm city
- Fort Collins
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28