Recall Z-1103-2020— Fridababy LLC
Class II · Ongoing
Class II FDA medical device recall by Fridababy LLC, initiated 2020-01-27. FDA's recall record names no specific 510(k) clearance for this event. Product: fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once. Reason: FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head..
- Recalling firm
- Fridababy LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-01-27
- Firm location
- Miami, FL, United States
Product description
fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
Reason for recall
FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head.
Data sourced from openFDA. This site is unofficial and independent of the FDA.