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  • sin3 replied to the topic FDA on Recalled Items in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago

    Many people may have heard of the recent recall on Sonic-Fusion’s flossing toothbrush. Just recently, this toothbrush was recalled due to “localized melting and sparking of the charging base.” There was an increasing amount of consumers reports of this malfunction, totaling to 3,800 units within a year. Many of the consumer’s had stopped using them and returned them to Water Pik inc. This overheating issue could have been avoided if there had were more testing on the battery during clinical trials, rather than the effect of the flossing toothbrush. There should have been more research done on the battery life as well and it’s effects after prolonged use. This recall was announced by the company, not the FDA, therefore the company is to blame for this incident.