Class II

Medical Device Recall: DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06

DeRoyal Industries Inc · October 3, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

160 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0307-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.