DeRoyal Industries Inc: Medical Device Recall in 2024 - (Recall #: Z-0306-2025)

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 C-SECTION TRACEPACK, REF 89-9338-06

Product Classification:

Class II

Date Initiated: October 3, 2024

Date Posted: November 13, 2024

Recall Number: Z-0306-2025

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: 780 units

Code Information:

UDI/ DI 00749756927864 (each), 50749756927869 (case): Lot Numbers: 59098305, exp 4/1/2027; 59161271, exp 3/1/2025; 59245221, exp 6/1/2025; 59287659, exp 5/1/2025; 59716337, exp 5/1/2025;59866546, exp 12/1/2025; 59962811, exp 11/1/2025; 59996754, exp 12/1/2025; 60104426, exp 11/1/2025

Distribution Pattern:

US Nationwide distribution in the state of OH.

Voluntary or Mandated:

Voluntary: Firm initiated