DeRoyal Industries Inc: Medical Device Recall in 2024 - (Recall #: Z-0307-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06

Product Classification:

Class II

Date Initiated: October 3, 2024

Date Posted: November 13, 2024

Recall Number: Z-0307-2025

Event ID: 95509

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.

Status: Ongoing

Product Quantity: 160 units

Code Information:

UDI/ DI 00749756916646 (each), 50749756916641 (case): Lot Numbers: lot 59839716 exp 12/1/2025

Distribution Pattern:

US Nationwide distribution in the state of OH.

Voluntary or Mandated:

Voluntary: Firm initiated