SUNSTAR G — Class II medical device recall Z-1837-2021
Terminated recall by Sunstar Americas, Inc., reported 2021-06-16, distributed nationwide. Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
| Recall number | Z-1837-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sunstar Americas, Inc., Schaumburg, IL, United States |
| Recall initiated | 2021-05-21 |
| Classified | 2021-06-09 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2024-09-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 124,064 units |
| Pathogens | burkholderia |
| Lot numbers | 01A, 01B, 01U, 01Z, 02A, 02B, 02U, 02Z, 03U, 03Z, 04Z, 05Z |
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.
Reason for recall
Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1837-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.