Cardinal Health Presource Kits: 1 ) KIT — Class II medical device recall Z-0914-2025
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-0914-2025 |
|---|---|
| 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 | 10195594665951, 10195594760984, 10195594788704, 10195594890407, 10197106000229, 10197106404751, 10197106452042, 50195594665959, 50195594760982, 50195594788702, 50195594890405, 50197106000227, 50197106404759, 50197106452040 |
| Lot numbers | 5891312, 6022131, 6025788, 6487904, 6788562, 6928760, 7280109, J6278R |
| Model numbers | PB11FSC10, PB11FSCH5, PB11FSCH6, PB11FSCH7, PB11FSCH8, PB11FSCH9, PB11FSCHR |
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
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-0914-2025. 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.