# FDA recall Z-0830-2021

> **Steris Corporation** · Class II · device recall initiated 2020-11-19.

## Product

Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing.

## Reason for recall

STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens.  The presence of this bacteria can cause the color of the detergent to darken over time.  There is an improbable risk to users of the product from exposure to this bacteria, and no risk to patients.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of CA, DE, CO, VA, FL, WA, TX, OH, PA, MA, IA, CT and the countries of United Kingdom, Saudi Arabia, Portugal, Denmark,  Ireland, United Arab Emirates, South Korea, Australia, Greece, Ashmore & Cartier Islands, Belgium, Canada, China, Germany, Japan, Norway, Poland, Qatar, Romania, Sweden, Thailand.

## Key facts

- **Recall number:** Z-0830-2021
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-19
- **Report date:** 2021-01-20
- **Termination date:** 2023-10-25

- **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-0830-2021

## Citation

> AI Analytics. FDA recall Z-0830-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0830-2021. Source: US FDA. Licensed CC0.

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