# FDA recall Z-2700-2020

> **Steris Corporation** · Class II · device recall initiated 2020-06-26.

## Product

InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

## Reason for recall

A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, and United Arab Emirates.

## Key facts

- **Recall number:** Z-2700-2020
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-26
- **Report date:** 2020-08-05
- **Termination date:** 2020-12-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mentor, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2700-2020

## Citation

> AI Analytics. FDA recall Z-2700-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2700-2020. Source: US FDA. Licensed CC0.

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