Recall Z-0307-2025— DeRoyal Industries Inc

Name: FDA recall Z-0307-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-03

Class II · Ongoing

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2024-10-03. It names one FDA 510(k) clearance: K842648. Product: DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06. Reason: 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..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-10-03
Firm location: Powell, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K842648 — GENERAL SURGERY TRAYDeroyal Industries, Inc.·cleared 1984-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.