# FDA recall Z-1837-2021

> **Sunstar Americas, Inc.** · Class II · device recall initiated 2021-05-21.

## 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.

## Distribution

Worldwide distribution - US Nationwide distribution and the country of Mexico.

## Key facts

- **Recall number:** Z-1837-2021
- **Recalling firm:** Sunstar Americas, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-21
- **Report date:** 2021-06-16
- **Termination date:** 2024-09-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Schaumburg, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1837-2021

## Citation

> AI Analytics. FDA recall Z-1837-2021. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1837-2021. Source: US FDA. Licensed CC0.

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