# FDA recall Z-0306-2025

> **DeRoyal Industries Inc** · Class II · device recall initiated 2024-10-03.

## Product

DeRoyal C-SECTION TRACEPACK, REF 89-9338-06

## Reason for recall

DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.

## Distribution

US Nationwide distribution in the state of OH.

## Key facts

- **Recall number:** Z-0306-2025
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-03
- **Report date:** 2024-11-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0306-2025

## Citation

> AI Analytics. FDA recall Z-0306-2025. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-0306-2025. Source: US FDA. Licensed CC0.

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