Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.
FDA Recall Z-2058-2012 · Posted 2012-07-20
Recalling FirmWestone Laboratories, Inc.
Recall StatusTerminated
Product CodeKMJ
Date Initiated2012-07-13
Date Terminated2012-12-14
Product QuantityApprox 100k sold annually x 15 years.
Reason for Recall
Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.
Firm Action
Westone Laboratories sent an Urgent Recall letter and Press Release to distributors and customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory, quarantine product subject to recall and discard or return the product to Westone. In addition, if the affected product have been further distributed please identify your customers and notify them at once of this product recall. Consumers with questions may contact Westone Laboratories at 1-800-357-3240 between the hours of 8:00am and 5:00pm MST or email at [email protected].
Root Cause
Material/Component Contamination
Distribution Pattern
Worlwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Brazil, Canada, France, Germany, Greece, Hong Kong, Ireland, Japan, Korea, Mexico, Panama, Philippines, Russian Federation, and Singapore, Sweden, Switzerland and Thailand and United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.