Westone Laboratories, Inc.
Colorado Springs, CO, US
WESTONE LABORATORIES, INC. appears in FDA device records in Colorado Springs, CO. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2094377 | 2094377 | WESTONE LABORATORIES, INC. | 2260 Executive Cirle, Colorado Springs, CO 80906 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2058-2012 | 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. | Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain