FDA Device recall Z-1136-2025

Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA

FDA Device
Class II
ongoing
Published 2025-02-19

On 2025-02-19 the FDA classified a Class II recall of Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA by Cardinal Health 200, citing potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1136-2025
Classification	Class II
Status	ongoing
Initiated	2024-11-08
Published	2025-02-19
Last updated	2026-09-13 11:57 UTC
Company	Cardinal Health 200
Distribution	US

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.

Identifiers

code_info	1) SEY30EYRVA, UDI-DI:10195594159382 (each) 50195594159380 (case), Lot Number: 5140378 ; 2) SEY30EYRVB, UDI-D… 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, UD

code_info

1) SEY30EYRVA, UDI-DI:10195594159382 (each) 50195594159380 (case), Lot Number: 5140378 ; 2) SEY30EYRVB, UDI-D…

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, UD

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1136-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.