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U.S. Department of Health and Human Services

Class 2 Device Recall Waterpik

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  Class 2 Device Recall Waterpik see related information
Date Initiated by Firm April 03, 2012
Date Posted May 25, 2012
Recall Status1 Terminated 3 on August 07, 2012
Recall Number Z-1674-2012
Recall Event ID 61532
Product Classification Irrigator, powered nasal - Product Code KMA
Product 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.
Code Information All lots and codes manufactured between May 2010 and July 2011.
Recalling Firm/
Water Pik, Inc.
1730 East Prospect Road
Fort Collins CO 80553-0001
For Additional Information Contact
Manufacturer Reason
for Recall
Customer complaints related to cross contamination of sinus rinse solution between the battery compartment and solution reservoir used for rinsing nasal passages.
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce 105257 individual units
Distribution US Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.