Recall archive / FDA device enforcement
Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO D... — FDA record Z-1136-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 973,785 total units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1136-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) SEY30EYRVA, UDI-DI:10195594159382 (each) 50195594159380 (case), Lot Number: 5140378 ; 2) SEY30EYRVB, UDI-DI:10195594555771 (each) 50195594555779 (case), Lot Number: 5970335 ; 3) SEY30EYRVB, UDI-DI:10195594555771 (each) 50195594555779 (case), Lot Number: 6133661 ; 4) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 6701854 ; 5) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 6702035 ; 6) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7266056 ; 7) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7280113 ; 8) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7280116 ; 9) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7320241 ; 10) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7331349 ; 11) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7331352 ; 12) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7332924 ; 13) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 7332923 ; 14) SEY30EYRVC, UDI-DI:10195594759735 (each) 50195594759733 (case), Lot Number: 6025793 ; 15) SEY35OP961, UDI-DI:10888439702651 (each) 50888439702659 (case), Lot Number: J46C12 ; 16) SEY35OP962, UDI-DI:10888439769005 (each) 50888439769003 (case), Lot Number: J4220A ; 17) SEY35OP96A, UDI-DI:10888439626698 (each) 50888439626696 (case), Lot Number: J46C10 ; 18) SEY35OP96A, UDI-DI:10888439626698 (each) 50888439626696 (case), Lot Number: J6372Z ; 19) SEY35OP96B, UDI-DI:10888439867541 (each) 50888439867549 (case), Lot Number: J79Z51 ; 20) SEY35OP96B, UDI-DI:10888439867541 (each) 50888439867549 (case), Lot Number: N/A ; 21) SEY35OP96B, UDI-DI:10888439867541 (each) 50888439867549 (case), Lot Number: J8393Z ; 22) SEY35OP96B, UDI-DI:10888439867541 (each) 50888439867549 (case), Lot Number: J6372Z ; 23) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6702038 ; 24) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6788692 ; 25) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6806122 ; 26) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7005495 ; 27) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7005496 ; 28) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7160517 ; 29) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7331480 ; 30) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7333444 ; 31) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7333444 ; 32) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7333446 ; 33) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 7360541 ; 34) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: J87C82 ; 35) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: J8998P ; 36) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5140388 ; 37) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: J6935J ; 38) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5533344 ; 39) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5664113 ; 40) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5664113 ; 41) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: J65K19 ; 42) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5664115 ; 43) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5876884 ; 44) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5918342 ; 45) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6251073 ; 46) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 5876884 ; 47) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6251076 ; 48) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6345528 ; 49) SEY35OP96C, UDI-DI:10888439984903 (each) 50888439984901 (case), Lot Number: 6701855 ; 50) SEY35OPBLX, UDI-DI:10888439516173 (each) 50888439516171 (case), Lot Number: J28W65 ; 51) SEY35OPBLY, UDI-DI:10888439586558 (each) 50888439586556 (case), Lot Number: J4220A ; 52) SEY35OPBLZ, UDI-DI:10888439611519 (each) 50888439611517 (case), Lot Number: J4220A ; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 19, 2025
- Recall initiation date
- Nov 8, 2024
- Center classification date
- Feb 10, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.