DeRoyal Industries Inc recalls DeRoyal C-SECTION TRACEPACK, REF 89-9338-06

Recall date

October 3, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0306-2025

FDA classification

Class II

Brand / firm

DeRoyal Industries Inc

Sold / distributed

US Nationwide distribution in the state of OH.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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