# FDA recall Z-1119-2022

> **Steris Corporation** · Class II · device recall initiated 2022-03-22.

## Product

Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm 	  	  Model Number: ENC4100

## Reason for recall

Product not approved for release for US distribution

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1119-2022
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-22
- **Report date:** 2022-06-01
- **Termination date:** 2024-01-29

- **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-1119-2022

## Citation

> AI Analytics. FDA recall Z-1119-2022. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-1119-2022. Source: US FDA. Licensed CC0.

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