Z-1674-2012

Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand...

Name: Z-1674-2012 Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand...
Creator: Water Pik, Inc.
Published: 2012-04-03
License: https://open.fda.gov/license/

Water Pik, Inc. / initiated 2012-04-03 / Terminated / root cause: design

FDA source

Water Pik, Inc. began a recall of Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft... on 2012-04-03. The reason FDA records is "Customer complaints related to cross contamination of sinus rinse solution between the battery compartment and solution reservoir used for rinsing nasal passages". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1674-2012
Status: Terminated
Initiated: 2012-04-03
Posted: 2012-05-25
Terminated: 2012-08-07
Recalling firm: Water Pik, Inc.
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.
Product code: KMA Irrigator, Powered Nasal
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: All lots and codes manufactured between May 2010 and July 2011.

Product code KMA

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)