FDA Medical Device Recalls (openFDA)
Del Laboratories Inc.: 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
- Recall number
- Z-1082-05
- 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
- Status
- Terminated
- Initiated
- 2005-06-09
- Posted
- 2005-08-03
- Terminated
- 2007-12-11
- Reason
- 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.
- 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 consumer_relations@orajel.com. 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
- 134,082 units domestically, and 1578 units internationally as samples
- Distribution
- Nationwide & Puerto Rico.
- Lot, serial or model codes
- Model 7531, barcode # 3 10310 32362 2 (This product does not have lot numbers assigned).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EFW
- Firm FEI
- 2410781
- Firm city
- Plainview
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28