DeRoyal Industries Inc: Medical Device Recall in 2023 - (Recall #: Z-2088-2023)

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) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478

Product Classification:

Class II

Date Initiated: May 30, 2023

Date Posted: July 12, 2023

Recall Number: Z-2088-2023

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: 328 packs

Code Information:

a) REF 89-10640, GTIN 50749756367740 (cs), 00749756367745 (unit), Lot Numbers: 58737945; b) REF 89-10901, GTIN 50749756380244 (cs), 00749756380249 (unit), Lot Numbers: 58820749; c) REF 89-1924, GTIN 50749756216864 (cs), 00749756216869 (unit), Lot Numbers: 58746227; d) REF 89-7133, GTIN 50749756736744 (cs), 00749756736749 (unit), Lot Numbers: 58789323; e) REF 89-9134, GTIN 50749756911332 (cs), 00749756911337 (unit), Lot Numbers: 58701336; f) REF 89-9478, GTIN 50749756926909 (cs), 00749756926904 (unit), Lot Numbers: 58738454

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated