Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DeRoyal C-SECTION TRACEPACK Recalled by DeRoyal Industries Inc Due to DeRoyal is recalling certain lots of surgical procedure...

Date: October 3, 2024
Company: DeRoyal Industries Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DeRoyal Industries Inc directly.

Affected Products

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

Quantity: 780 units

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About DeRoyal Industries Inc

DeRoyal Industries Inc has 225 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report