Westone Laboratories is initiating a voluntary nationwide recall of all sizes and packaging configurations of Oto-Ease ear lubricant due to possible contamination with pathogenic bacteria and mold. The contamination may result in infectious complications of the ear canal and surrounding tissues.
The Oto-Ease unit containers are not identified with a lot number, expiration date, or UPC Code. The affected packaging configurations include 0.5oz 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 writing.
Oto-Ease ear lubricant is indicated for easing the insertion of custom fit ear molds and hearing instruments (including hearing aids). This product was previously recalled in October 2011.
For more information call (800) 357-3240 or visit http://www.fda.gov/Safety/Recalls/ucm311978.htm.