Recall Z-2734-2018— Water Pik, Inc.
Class II · Terminated
Class II FDA medical device recall by Water Pik, Inc., initiated 2018-07-02, terminated 2022-05-24. FDA's recall record names no specific 510(k) clearance for this event. 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: Charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns..
- Recalling firm
- Water Pik, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-02
- Terminated
- 2022-05-24
- Firm location
- Fort Collins, CO, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.