Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK — Class II medical device recall Z-1136-2025
Ongoing recall by Cardinal Health 200, LLC, reported 2025-02-19, distributed nationwide. Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
| Recall number | Z-1136-2025 |
|---|---|
| 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 | 2025-02-10 |
| Reported by FDA | 2025-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, SA |
| Quantity | 973,785 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10195594159382, 10195594555771, 10195594759735, 10888439516173, 10888439586558, 10888439611519, 10888439626698, 10888439702651, 10888439769005, 10888439867541, 10888439984903, 50195594159380, 50195594555779, 50195594759733, 50888439516171, 50888439586556, 50888439611517, 50888439626696, 50888439702659, 50888439769003, 50888439867549, 50888439984901 |
| Lot numbers | 5140378, 5140388, 5533344, 5664113, 5664115, 5876884, 5918342, 5970335, 6025793, 6133661, 6251073, 6251076, 6345528, 6701854, 6701855, 6702035, 6702038, 6788692, 6806122, 7005495, 7005496, 7160517, 7266056, 7280113, 7280116, 7320241, 7331349, 7331352, 7331480, 7332923, 7332924, 7333444, 7333446, 7360541, J28W65, J4220A, J46C10, J46C12, J6372Z, J65K19 and 5 more |
| Model numbers | SEY30EYRVA, SEY30EYRVB, SEY30EYRVC, SEY35OP961, SEY35OP962, SEY35OP96A, SEY35OP96B, SEY35OP96C, SEY35OPBLX, SEY35OPBLY, SEY35OPBLZ |
Product
Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5) OCULAR PLASTIC PACK, Catalog Number:SEY35OP962 6) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96A 7) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96B 8) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96C 9) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLX 10) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLY 11) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLZ
Reason for recall
Potential for 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-1136-2025. 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.