Z-2058-2012Class II

Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi...

Name: Z-2058-2012 Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi...
Creator: Westone Laboratories, Inc.
Published: 2012-07-13
License: https://open.fda.gov/license/

Westone Laboratories, Inc. / initiated 2012-07-13 / Terminated / root cause: manufacturing process

FDA source

Westone Laboratories, Inc. began a recall of 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... on 2012-07-13. FDA classified it as Class II and gives the reason as "Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2058-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-13
Posted: 2012-07-20
Terminated: 2012-12-14
Recalling firm: Westone Laboratories, Inc.
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.
Product code: KMJ Lubricant, Patient
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Westone Laboratories sent an Urgent Recall letter and Press Release to distributors and customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory, quarantine product subject to recall and discard or return the product to Westone. In addition, if the affected product have been further distributed please identify your customers and notify them at once of this product recall. Consumers with questions may contact Westone Laboratories at 1-800-357-3240 between the hours of 8:00am and 5:00pm MST or email at [email protected].
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2058-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2058-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-20

Product code KMJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)