Z-1082-05

Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be...

Name: Z-1082-05 Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be...
Creator: Del Laboratories Inc.
Published: 2005-06-09
License: https://open.fda.gov/license/

Del Laboratories Inc. / initiated 2005-06-09 / Terminated

FDA source

Del Laboratories Inc. began a recall of Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be replaced every 3 months. --- Firm on label: DEL... on 2005-06-09. The reason FDA records is "Firm received several consumer complaints that the elastomer head of the toothbrush had separated (broke) from the handle during use and could pose a choking hazard to children". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1082-05
Status: Terminated
Initiated: 2005-06-09
Posted: 2005-08-03
Terminated: 2007-12-11
Recalling firm: Del Laboratories Inc.
Product: Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be replaced every 3 months. --- Firm on label: DEL PHARMACEUTICALS, INC. a subsidiary of Del Laboratories, Inc. Uniondale, NY 11553
Product code: EFW Toothbrush, Manual
Reason for recall: Firm received several consumer complaints that the elastomer head of the toothbrush had separated (broke) from the handle during use and could pose a choking hazard to children.
FDA root cause: Other
Action: Recall letters were sent on 6/09/05 by FedEx to direct wholesalers/distributors and retailers nationwide. A nationwide press release was issued on 6/10/05, and notification sent to numerous consumer & parenting publications, plus posting on company website. Questions from consumers should be referred to Del Pharmaceuticals at 1-800-818-1915 or by email at [email protected]. Recall letters were sent to 3 direct accounts on 7/21/05 via FedEx after the discovery that these accounts had not been notified.
Quantity in commerce: 134,082 units domestically, and 1578 units internationally as samples
Distribution: Nationwide & Puerto Rico.
Product codes and lots: Model 7531, barcode # 3 10310 32362 2 (This product does not have lot numbers assigned).

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)