DeRoyal Industries Inc: Medical Device Recall in 2023 - (Recall #: Z-0116-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit

Product Classification:

Class II

Date Initiated: September 18, 2023

Date Posted: October 25, 2023

Recall Number: Z-0116-2024

Event ID: 93078

Reason for Recall:

DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.

Status: Ongoing

Product Quantity: 32 kits

Code Information:

UDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027

Distribution Pattern:

Pennsylvania

Voluntary or Mandated:

Voluntary: Firm initiated