Westone Recalls Oto Ease Ear Lubricant Due to Microbial Contamination
Westone Laboratories is recalling all Oto Ease ear lubricant products due to potential microbial contamination. The product is used to ease the insertion of hearing aids and earmolds.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential microbial contamination, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Westone Laboratories, Inc. is recalling all Oto Ease ear lubricant products in all packaging configurations and sizes. The recall is being conducted due to potential microbial contamination of the product. Oto Ease is labeled as a bacteria-free, greaseless lubricant sold in 0.5 oz consumer-sized semi-transparent flexible plastic bottles. It is used as a patient lubricant to ease the insertion of earmolds and hearing instruments such as hearing aids.
The source text does not specify a particular lot number or expiration date for the affected units, noting that individual products are not identified with lot numbers and no expiry is applied to the finished products. The recall covers worldwide distribution, including the United States and various international markets.
Consumers should stop using the product immediately. The source text does not provide specific instructions for disposal or replacement, but users should contact Westone Laboratories or their healthcare provider for further guidance.
The recalled product
- 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…
- Manufacturer
- Westone Laboratories, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
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