Class II — Sunstar Americas, Inc.
| Recalling firm | Sunstar Americas, Inc. |
|---|---|
| Registered facility | SUNSTAR AMERICAS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans. |
| Product | SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria. |
| Quantity | 124064 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Mexico. |
| Initiated | 2021-05-21 |
| Classified | 2021-06-09 |
| Terminated | 2024-09-04 |
| Recall number | Z-1837-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sunstar Americas, Inc. (Z-1837-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87976/
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