Sunstar Americas, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1182-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 18, 2021

Date Posted: March 17, 2021

Recall Number: Z-1182-2021

Event ID: 87371

Reason for Recall:

The product may be contaminated with Burkholderia cepacia

Status: Terminated

Product Quantity: 56960 bottles

Code Information:

All lot codes within expiry

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated