Cardinal Health 200, LLC: Medical Device Recall in 2025 - (Recall #: Z-0909-2025)

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 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMP:;

Product Classification:

Class II

Date Initiated: November 8, 2024

Date Posted: January 22, 2025

Recall Number: Z-0909-2025

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 SBAOCTEHH1, UDI/DI 10195594722685 (EA)50195594722683 (CS), Lot Number 21J2883 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1029 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1029 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 23F1437 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 23F1437 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18E1332 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18H2278 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18J2582 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18M3535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18M3535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19A0124 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19E1525 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19K3308 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number N/A ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19K3308 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19C0888 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18H2278 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19C0888 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19A0124 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 19B0560 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SEN15SERM5, UDI/DI 10195594423469 (EA)50195594423467 (CS), Lot Number 5533336 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J3987C ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J43U74 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J46A98 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J46C04 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J72P53 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J8393W ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J6050H ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number J86T82 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number 5140356 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number 5891304 ; Catalog Number SEN15SERMO, UDI/DI 10887488074634 (EA)50887488074632 (CS), Lot Number 6264567 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 6928759 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 7163104 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 7331342 ; Catalog Number SEN15SERMP, UDI/DI 10197106481400 (EA)50197106481408 (CS), Lot Number 7332908 ;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated