Cardinal Health 200, LLC: Medical Device Recall in 2025 - (Recall #: Z-0914-2025)

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 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7 5 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH8 6 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH9 7 ) KIT, FETAL SURGERY , Catalog Number PB11FSCHR

Product Classification:

Class II

Date Initiated: November 8, 2024

Date Posted: January 22, 2025

Recall Number: Z-0914-2025

Event ID: 95722

Reason for Recall:

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

Status: Ongoing

Product Quantity: 512,786 total units

Code Information:

Catalog Number PB11FSC10, UDI/DI 10197106452042 (EA)50197106452040 (CS), Lot Number 6928760 ; Catalog Number PB11FSCH5, UDI/DI 10195594665951 (EA)50195594665959 (CS), Lot Number 5891312 ; Catalog Number PB11FSCH6, UDI/DI 10195594760984 (EA)50195594760982 (CS), Lot Number 6022131 ; Catalog Number PB11FSCH7, UDI/DI 10195594788704 (EA)50195594788702 (CS), Lot Number 6025788 ; Catalog Number PB11FSCH8, UDI/DI 10197106000229 (EA)50197106000227 (CS), Lot Number J6278R ; Catalog Number PB11FSCH9, UDI/DI 10197106404751 (EA)50197106404759 (CS), Lot Number 6788562 ; Catalog Number PB11FSCHR, UDI/DI 10195594890407 (EA)50195594890405 (CS), Lot Number 7280109 ; Catalog Number PB11FSCHR, UDI/DI 10195594890407 (EA)50195594890405 (CS), Lot Number 6487904 ;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated