# FDA recall Z-2178-2025

> **Steris Corporation** · Class II · device recall initiated 2025-06-23.

## Product

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

## Reason for recall

The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.

## Distribution

Worldwide - US Nationwide and Puerto Rico and the country of Canada.

## Key facts

- **Recall number:** Z-2178-2025
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-23
- **Report date:** 2025-08-06

- **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-2178-2025

## Citation

> AI Analytics. FDA recall Z-2178-2025. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2178-2025. Source: US FDA. Licensed CC0.

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