DeRoyal Industries Inc: Medical Device Recall in 2023 - (Recall #: Z-0927-2023)

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 ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10

Product Classification:

Class II

Date Initiated: December 12, 2022

Date Posted: January 18, 2023

Recall Number: Z-0927-2023

Event ID: 91331

Reason for Recall:

DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.

Status: Ongoing

Product Quantity: 157 packs

Code Information:

a) REF 89-9004.09, GTIN 00749756903936, Lot Numbers: 57391129 exp 5/1/2023, 57755421 exp 5/1/2023, 57900931 exp 5/1/2023 b) REF 89-9004.10, GTIN 00749756903931, Lot Numbers: 57913767 exp 5/1/2023

Distribution Pattern:

US Nationwide distribution in the states of IL, MO.

Voluntary or Mandated:

Voluntary: Firm initiated