Class II — Cardinal Health 200, LLC
| Recalling firm | Cardinal Health 200, LLC |
|---|---|
| Registered facility | View this company's 35 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| Product | 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 |
| Quantity | 512,786 total units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia. |
| Initiated | 2024-11-08 |
| Classified | 2025-01-15 |
| Recall number | Z-0914-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cardinal Health 200, LLC (Z-0914-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95722/
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