Cardinal Health 200, LLC: Medical Device Recall in 2025 - (Recall #: Z-1128-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC

Product Classification:

Class II

Date Initiated: November 8, 2024

Date Posted: February 19, 2025

Recall Number: Z-1128-2025

Event ID: 95947

Reason for Recall:

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Status: Ongoing

Product Quantity: 973,785 total units

Code Information:

1) SOT4FRUWFA, UDI-DI:10197106526187 (each) 50197106526185 (case), Lot Number: 7266123 ; 2) SOT4FRUWFA, UDI-DI:10197106526187 (each) 50197106526185 (case), Lot Number: 7331357 ; 3) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7266123 ; 4) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7333452 ; 5) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7333453 ; 6) SOT4FRUWFC, UDI-DI:10197106732304 (each) 50197106732302 (case), Lot Number: 7350031 ;

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated