# FDA recall Z-0781-2023

> **Steris Corporation** · Class II · device recall initiated 2022-12-12.

## Product

VERIFY Steam Test Pack (20 Tests and 20 controls)  Item Number: S3069    Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes

## Reason for recall

Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.

## Distribution

Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA

## Key facts

- **Recall number:** Z-0781-2023
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-12
- **Report date:** 2023-01-11

- **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-0781-2023

## Citation

> AI Analytics. FDA recall Z-0781-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0781-2023. Source: US FDA. Licensed CC0.

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