DeRoyal Industries Inc: Medical Device Recall in 2023 - (Recall #: Z-2089-2023)

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:

Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219

Product Classification:

Class II

Date Initiated: May 30, 2023

Date Posted: July 12, 2023

Recall Number: Z-2089-2023

Event ID: 92445

Reason for Recall:

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Status: Ongoing

Product Quantity: 3 packs

Code Information:

a) REF 89-6219, GTIN 50749756664382 (cs), 00749756664387 (unit), Lot Numbers: 58807114

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated