Class II — Westone Laboratories, Inc.
| Recalling firm | WESTONE LABORATORIES, INC. |
|---|---|
| Registered facility | WESTONE LABORATORIES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product. |
| Product | 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. |
| Quantity | Approx 100k sold annually x 15 years. |
| Distribution | 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. |
| Initiated | 2012-07-13 |
| Classified | 2012-07-20 |
| Terminated | 2012-12-14 |
| Recall number | Z-2058-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Westone Laboratories, Inc. (Z-2058-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62520/
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