# FDA recall Z-1457-2022

> **Davol, Inc.** · Class II · device recall initiated 2022-06-27.

## Product

X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)

## Reason for recall

The device may potentially cause a fire, leading to a safety risk.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada and Chile.

## Key facts

- **Recall number:** Z-1457-2022
- **Recalling firm:** Davol, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-27
- **Report date:** 2022-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warwick, RI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1457-2022

## Citation

> AI Analytics. FDA recall Z-1457-2022. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-1457-2022. Source: US FDA. Licensed CC0.

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