# FDA recall Z-0995-2019

> **Steris Corporation** · Class II · device recall initiated 2018-12-20.

## Product

AMSCO 3000 Series Washer/Disinfector Model # 3052

## Reason for recall

The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.

## Distribution

The products were distributed to the following US states:  AL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV.    The products were distributed to the following foreign countries:  Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, and Taiwan.

## Key facts

- **Recall number:** Z-0995-2019
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-12-20
- **Report date:** 2019-03-20
- **Termination date:** 2019-07-22

- **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-0995-2019

## Citation

> AI Analytics. FDA recall Z-0995-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0995-2019. Source: US FDA. Licensed CC0.

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