Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Oto Ease by Westone Recalled by Westone Laboratories, Inc. Due to Westone is recalling all Oto Ease ear lubricant...

Date: July 13, 2012
Company: Westone Laboratories, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Westone Laboratories, Inc. directly.

Affected Products

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.

Why Was This Recalled?

Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Westone Laboratories, Inc.

Westone Laboratories, Inc. has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report