Westone Laboratories, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2058-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 13, 2012

Date Posted: August 1, 2012

Recall Number: Z-2058-2012

Event ID: 62520

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.

Status: Terminated

Product Quantity: Approx 100k sold annually x 15 years.

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated