Oto-Ease Ear Lubricant Recall Issued Due to Bacteria, Mold Contamination

A nationwide recall has been issued for Oto-Ease ear lubricant, due to concerns that the product may be contaminated with bacteria and mold. 

The product was previously pulled from store shelves in the United States and Australia in October 2011, but that was done without FDA knowledge. According to a recall notice posted by the FDA last week, a consumer complaint and FDA sample analysis has detected that the ear lubricant is contaminated, and may result in infectious complications of the ear canal and surrounding tissues.

Oto-Ease ear lubricant is used during insertion of custom fit ear molds and hearing instruments.

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Although there have been no consumer reports involving infection reportedly caused by the ear lubricant, consumers have been advised to immediately stop using the product and contact their healthcare provider.

The recalled Oto-Ease ear lubricant comes in 0.5 oz semi transparent flexible plastic bottles with orange or semi transparent plastic screw-on dispensing caps, and aluminum foil single use sample packs with red or black print writing. Oto-Ease unit containers are not identified with a lot number, expiration date, or UPC Code.

The lubricant was distributed to retail stores, health care professionals and hospitals in the U.S., Belgium, Greece, Canada, Thailand, Australia, Panama, Singapore, Russian Federation, Ireland, The Philippines, France, Korea, United Kingdom, Switzerland, Brazil, Japan, Germany, Mexico, Hong Kong, and Sweden

The company is currently notifying distributors and customers through direct letter. They are also arranging for the disposal or return of all recalled products. They can be reached at 1-800-357-3240 between the hours of 8:00am and 5:00pm MST or via email at customerservice@westone.com.


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