CLASS II Device recall · Reported 1 Aug 2012 · FDA Enforcement Report

Oto Ease by Westone, labeled as a bacteria free recalled

Westone Laboratories is recalling Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant, distributed nationwide in the US. The recall was initiated on 13 Jul 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesIndividual products are not identified with lot numbers. There may be lot numbers on the bottom of the bulk packaging of a twelve pack of individual products but the end user may not be aware of a lot number for the specific vial. No expiry is applied to the finished products.

Quantity recalledApprox 100k sold annually x 15 years.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2058-2012
FDA event ID: 62520
Recalling firm: Westone Laboratories, Colorado Springs, CO
Classification: Class II
Status: Terminated
Recall initiated: 13 Jul 2012
FDA classified: 20 Jul 2012
Reported: 1 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Device type: Hearing Aids

Timeline

13 Jul 2012	Recall initiated by company
20 Jul 2012	Classified by FDA	+7 days
1 Aug 2012	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Individual products are not identified with lot numbers. There may be lot numbers on the bottom of the bulk packaging of a twelve pack of individual products but the end user may not be aware of a lot number for the specific vial. No expiry is applied to the finished products.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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