Data Foundry

Medical device recalls 2018

Waterpik Sonic-Fusion Professional — Class II medical device recall Z-2734-2018

Terminated recall by Water Pik, Inc., reported 2018-08-15, distributed nationwide. Charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns.

Recall numberZ-2734-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmWater Pik, Inc., Fort Collins, CO, United States
Recall initiated2018-07-02
Classified2018-08-08
Reported by FDA2018-08-15
Terminated2022-05-24
DistributedNationwide (US)
Countries outside the USCA
Quantity3,797
Reason classesdevice malfunction
Serial numbersSF02
Model numbersSF-02

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2734-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.