Reason for the Voluntary Recall:
The products have been found through a consumer complaint and the U.S. Food and Drug Administration (FDA) sample analysis to be potentially contaminated with pathogenic bacteria and mold. The scope of this recall extends to all sizes and packaging configurations of Oto-Ease as the distinction between lots
cannot be determined.
Risk to Health:
Use of the product as directed for easing the insertion of custom fit ear molds and hearing instruments could result in infectious complications of the ear canal and surrounding tissues. No injuries or illnesses have been reported to date.
Actions to be taken by the Customer/User:
Consumers who have any size or packaging configuration should stop using the product and contact theirhealthcare provider. Packaging configurations include the following:
1) 0.5 oz semi transparent flexible plastic bottles with orange or semi transparent plastic screw-on
dispensing caps
2) aluminum foil single use sample packs with red or black print writing.
The Oto-Ease unit containers are not identified with a lot number, expiration date, or UPC Code.
If you have any of these products, please destroy or return them. 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 otoeaserecall@westone.com.
This recall is being made with the knowledge of the Food and Drug Administration. Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Events Program either online, by regular mail or by fax:
- Online: www.fda.gov/medwatch/report.htm
- Regular mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm
- Fax: 1-800-FDA-0178
Westone is currently researching a substitute product for sale in the future and will notify customers when that product is available.
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