Westone Laboratories Inc., a manufacturer of custom ear molds for hearing healthcare and other applications, is recalling all sizes and packaging configurations of Oto-Ease ear lubricant due to possible microbial contamination.
Oto-Ease is a lubricant that helps ease insertion of ear molds and hearing aids. This product was previously recalled in October 2011 within the United States and from Australia (without FDA knowledge).
The affected products include, 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.
The products were distributed to hospitals, health professionals, and retailers nationwide and to Belgium, Greece, Canada, Thailand, Australia, Panama, Singapore, Russian Federation, Ireland, The Philippines, France, Korea, United Kingdom, Switzerland, Brazil, Japan, Germany, Mexico, Hong Kong, Sweden, according to a statement from the FDA.
The recall has been initiated following a consumer complaint, and sample analysis by the FDA has found the product to be potentially contaminated with pathogenic bacteria and mold. Using the affected product could result in infectious complications of the ear canal and surrounding tissues, warns the U.S. regulatory agency.
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