FDAClass IIFebruary 19, 2020

fridababy SmileFrida the TOOTHHUGGER 18+ months Triple recall: Foreign Material

fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once

Why was fridababy SmileFrida the TOOTHHUGGER 18+ months Triple recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lots

Product
fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
Recalling firm
Fridababy LLC
Quantity
480,144
Distribution
Nationwide. International distribution to Canada, Mexico, Nicaragua, Dominican Republic, Honduras, Chile, Peru, Qatar. No US governmental consignees.
Recall date
February 19, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls