Cardinal Health Presource Kits: 1 ) ANEURYSM PACK — Class II medical device recall Z-0910-2025

Ongoing recall by Cardinal Health 200, LLC, reported 2025-01-22, distributed nationwide. Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Recall number	`Z-0910-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Cardinal Health 200, LLC, Waukegan, IL, United States
Recall initiated	2024-11-08
Classified	2025-01-15
Reported by FDA	2025-01-22
Distributed	Nationwide (US)
Countries outside the US	CA, SA
Quantity	512,786 units
Reason classes	sterility
UPC / GTIN / UDI-DI	`10195594031701`, `10195594127664`, `10888439782530`, `10888439834239`, `10888439931624`, `50195594031709`, `50195594127662`, `50888439782538`, `50888439834237`, `50888439931622`
Lot numbers	`5136034`, `J53W78`, `J5678Z`, `J6049R`, `J6050A`, `J6367C`, `J6367G`, `J7412G`, `J74A27`, `J7905J`, `J8124C`, `J8393C`, `J9602R`, `J9602W`, `J9850D`
Model numbers	`SCVHFAPBM1`, `SCVHFAPBM3`, `SCVHFAPBM5`, `SCVHFAPBM6`, `SCVHFAPBM7`

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 for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0910-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.