CLASS II ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report
Cardinal Health Presource Kits: Ophthalmology Endo Dcr Xtrs PK recalled
Cardinal Health 200 is recalling Cardinal Health Presource Kits: Ophthalmology Endo Dcr Xtrs PK, distributed nationwide in the US. The recall was initiated on 8 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1136-2025
- FDA event ID
- 95947
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Nov 2024
- FDA classified
- 10 Feb 2025
- Reported
- 19 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 8 Nov 2024 | Recall initiated by company | |
| 10 Feb 2025 | Classified by FDA | +94 days |
| 19 Feb 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Questions about this recall
Is Cardinal Health Presource Kits: Ophthalmology Endo Dcr Xtrs PK recalled?
Yes. Cardinal Health 200 recalled Cardinal Health Presource Kits: Ophthalmology Endo Dcr Xtrs PK on 8 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-1136-2025.
Why was it recalled?
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Which lots are affected?
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 ;
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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