The Recall Desk

Manufacturer

Westone Laboratories, Inc.

1 recall in our database name Westone Laboratories, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2012-08-01

Of the 1 recalls from Westone Laboratories, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-2058-2012·2012-08-01

    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.

    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 heari
    Category
    Medical Device
    Distribution
    Distributed nationwide