Medical device recalls Moderate risk

Sunstar Americas, Inc. recalls SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is…

Recall date
February 18, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1182-2021
FDA classification
Class II
Brand / firm
Sunstar Americas, Inc.
Sold / distributed
US Nationwide distribution.

Why it was recalled

The product may be contaminated with Burkholderia cepacia

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth.

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