DeRoyal Industries Inc: Device Recall

Recall Details

Recall Number

Z-0307-2025

Classification

Class II

Product Type

Device

Recalling Firm

DeRoyal Industries Inc

Status

Ongoing

Date Initiated

10/03/2024

Location

Powell, TN, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

160 units

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.

Product Description

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

Distribution Pattern

US Nationwide distribution in the state of OH.

Other Recalls by DeRoyal Industries Inc

• Class II: Risk 01/31/2025
  Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.
• Class II: Risk 01/15/2025
  The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.
• Class II: Risk 10/03/2024
  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: Risk 10/03/2024
  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: Risk 10/03/2024
  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.

View all recalls by DeRoyal Industries Inc →