FDA Medical Device Recalls (openFDA)
Sunstar Americas, Inc.: 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.
- Recall number
- Z-1182-2021
- Recalling firm
- Sunstar Americas, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2021-02-18
- Posted
- not on file
- Terminated
- 2024-09-30
- Reason
- The product may be contaminated with Burkholderia cepacia
- Root cause
- Process control
- Action
- The firm initiated the recall by letter and public notice on 02/18/2021. The letter stated that hazard and requested the return of the product.
- Quantity
- 56960 bottles
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- All lot codes within expiry
- 510(k) numbers
- ["K181134"]
- PMA numbers
- not on file
- Product code
- LFD
- Firm FEI
- 1413787
- Firm city
- Schaumburg
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28