DeRoyal Industries Inc: Medical Device Recall in 2022 - (Recall #: Z-0561-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15

Product Classification:

Class II

Date Initiated: November 3, 2022

Date Posted: December 21, 2022

Recall Number: Z-0561-2023

Event ID: 91134

Reason for Recall:

DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Status: Ongoing

Product Quantity: 828 kits

Code Information:

Lot Numbers: Lot 56185163 exp 2/1/2024; Lot 56390466 exp 2/1/2024; Lot 56616859 exp 2/1/2024; Lot 57390901 exp 1/1/2024; Lot 57466813 exp 10/1/2024; Lot 57589987 exp 6/1/2024; Lot 57674444 exp 6/1/2024

Distribution Pattern:

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Voluntary or Mandated:

Voluntary: Firm initiated