Z-1103-2020Class II

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

Name: Z-1103-2020 fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
Creator: Fridababy LLC
Published: 2020-01-27
License: https://open.fda.gov/license/

FridaBaby LLC / initiated 2020-01-27 / Open, Classified / root cause: labeling and UDI

FDA source

Fridababy LLC began a recall of fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once on 2020-01-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1103-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-01-27
Posted: 2020-01-30
Recalling firm: FridaBaby LLC
Product: fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
Product code: EFW Toothbrush, Manual
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.
Root cause tag: labeling and UDI
FDA root cause: Use error
Action: Consignees will be notified via email with recall letter. The letter identifies affected product, stated reason for recall, and request to inspect the product for evidence of misuse and discard if necessary. If product has not been used, the consignee is reminded to follow the product labeling. A response to the recall notification via email is requested.
Quantity in commerce: 480,144
Distribution: Nationwide. International distribution to Canada, Mexico, Nicaragua, Dominican Republic, Honduras, Chile, Peru, Qatar. No US governmental consignees.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1103-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1103-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-02-19	2020-02-07

Product code EFW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)