Events

Recall of Waterpik

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Water Pik, 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
    61532
  • Event Risk Class
    Class 2
  • Event Number
    Z-1674-2012
  • Event Initiated Date
    2012-04-03
  • Event Date Posted
    2012-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108365
  • 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
    Irrigator, powered nasal - Product Code KMA
  • Reason
    Customer complaints related to cross contamination of sinus rinse solution between the battery compartment and solution reservoir used for rinsing nasal passages.
  • Action
    Water Pik has generated a Press Release letter dated May 2012. The letter included safety information and instructions for the consumer to contact Waterpik for a replacement model if they experience water intrusion into the battery compartment of their device. For additional information go to www.waterpiksinusense.com/exchange.

Device

Waterpik
  • Model / Serial
    All lots and codes manufactured between May 2010 and July 2011.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. || Product Usage: Sinus washing device to keep sinus passages clear of congestion.
  • Manufacturer
    Water Pik, Inc.

Manufacturer

Water Pik, Inc.
  • Manufacturer Address
    Water Pik, Inc., 1730 East Prospect Road, Fort Collins CO 80553-0001
  • Manufacturer Parent Company (2017)
    Church & Dwight Co., Inc.
  • Source
    USFDA