Events

Recall of Device Recall Orajel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Del Laboratories Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    32593
  • Event Risk Class
    Class 2
  • Event Number
    Z-1082-05
  • Event Initiated Date
    2005-06-09
  • Event Date Posted
    2005-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40402
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Toothbrush, Manual - Product Code EFW
  • 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.
  • 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.

Device

Device Recall Orajel
  • Model / Serial
    Model 7531, barcode # 3 10310 32362 2 (This product does not have lot numbers assigned).
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide & Puerto Rico.
  • Product Description
    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
  • Manufacturer
    Del Laboratories Inc.

Manufacturer

Del Laboratories Inc.
  • Manufacturer Address
    Del Laboratories Inc., 55 West Ames Court, Suite 100, Plainview NY 11803
  • Source
    USFDA