FDA Device recall Z-0910-2025

Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1

FDA Device
Class II
ongoing
Published 2025-01-22

On 2025-01-22 the FDA classified a Class II recall of Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1 by Cardinal Health 200, citing potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0910-2025
Classification	Class II
Status	ongoing
Initiated	2024-11-08
Published	2025-01-22
Last updated	2026-09-13 11:57 UTC
Company	Cardinal Health 200
Distribution	US

Product

Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5; 4 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM6; 5 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM7

Reason

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

Identifiers

code_info	Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J5678Z ; Catalog Number… Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J5678Z ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number N/A ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J6049R ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J53W78 ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J74A27 ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J7412G ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number N/A ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J6050A ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931622 (CS), Lot Number J8124C ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931

code_info

Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J5678Z ; Catalog Number…

Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J5678Z ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number N/A ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J6049R ; Catalog Number SCVHFAPBM1, UDI/DI 10888439782530 (EA)50888439782538 (CS), Lot Number J53W78 ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J74A27 ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J7412G ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number N/A ; Catalog Number SCVHFAPBM3, UDI/DI 10888439834239 (EA)50888439834237 (CS), Lot Number J6050A ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931622 (CS), Lot Number J8124C ; Catalog Number SCVHFAPBM5, UDI/DI 10888439931624 (EA)50888439931

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0910-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.