# FDA recall Z-0121-2022

> **Fort Defiance Industries, LLC** · Class II · device recall initiated 2021-08-19.

## Product

P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641

## Reason for recall

The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.

## Distribution

Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.

## Key facts

- **Recall number:** Z-0121-2022
- **Recalling firm:** Fort Defiance Industries, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-19
- **Report date:** 2021-10-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Loudon, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0121-2022

## Citation

> AI Analytics. FDA recall Z-0121-2022. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0121-2022. Source: US FDA. Licensed CC0.

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