Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK — Class II medical device recall Z-0909-2025
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-0909-2025 |
|---|---|
| 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 | 10195594423469, 10195594722685, 10197106481400, 10887488074634, 10888439551662, 50195594423467, 50195594722683, 50197106481408, 50887488074632, 50888439551660 |
| Lot numbers | 18E1332, 18H2278, 18J2582, 18M3535, 19A0124, 19B0560, 19C0888, 19E1525, 19K3308, 21J2883, 22D1028, 22D1029, 23F1437, 24C0535, 5140356, 5533336, 5891304, 6264567, 6928759, 7163104, 7331342, 7332908, J3987C, J43U74, J46A98, J46C04, J6050H, J72P53, J8393W, J86T82 |
| Model numbers | SBAOCTEHH1, SEN15SERM5, SEN15SERMO, SEN15SERMP |
Product
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:;
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-0909-2025. 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.