Recall archive / FDA device enforcement
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1... — FDA record Z-1134-2025
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) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT, CRANIOTOMY, Catalog Number:PN11CNC11 23) KIT, CRANIOTOMY, Catalog Number:PN11CNC12 24) KIT, CRANIOTOMY, Catalog Number:PN11CNC13 25) KIT, CRANIOTOMY, Catalog Number:PN11CNC14 26) KIT, CRANIOTOMY, Catalog Number:PN11CNC15 27) KIT, CRANIOTOMY, Catalog Number:PN11CNC16 28) KIT, CRANIOTOMY, Catalog Number:PN11CNC17 29) KIT, CRANIOTOMY, Catalog Number:PN11CNC18 30) KIT, CRANIOTOMY, Catalog Number:PN11CNC19 31) KIT, CRANIOTOMY, Catalog Number:PN11CNC20 32) KIT, CRANIOTOMY, Catalog Number:PN11CNCH7 33) KIT, CRANIOTOMY, Catalog Number:PN11CNCH8 34) KIT, CRANIOTOMY, Catalog Number:PN11CNCH9 35) KIT, CRANIOTOMY, Catalog Number:PN11CNCHN 36) KIT, CRANIOTOMY, Catalog Number:PN11CNCHO 37) KIT, CRANIOTOMY, Catalog Number:PN11CNCHQ 38) KIT, CRANIOTOMY, Catalog Number:PN11CNCHR 39) KIT, CRANIOTOMY, Catalog Number:PN11CNCHS 40) KIT, CRANIOTOMY, Catalog Number:PN11CNCHT 41) KIT, CRANIOTOMY, Catalog Number:PN11CNCHU 42) KIT, CRANIOTOMY, Catalog Number:PN11CNCHV 43) KIT, NEURO SJMC, Catalog Number:PN11NEXX2 44) KIT, NEURO SJMC, Catalog Number:PN11NEXX3 45) KIT, NEURO SJMC, Catalog Number:PN11NEXX4 46) KIT, NEURO SJMC, Catalog Number:PN11NEXX5 47) KIT, NEURO SJMC, Catalog Number:PN11NEXX6 48) KIT, NEURO SJMC, Catalog Number:PN11NEXX7 49) KIT, NEURO SJMC, Catalog Number:PN11NEXXB 50) KIT, NEURO SJMC, Catalog Number:PN11NEXXD 51) KIT, NEURO SJMC, Catalog Number:PN11NEXXE 52) KIT, NEURO, Catalog Number:PN11OTR10 53) KIT, NEURO, Catalog Number:PN11OTR11 54) KIT, NEURO, Catalog Number:PN11OTR12 55) KIT, NEURO, Catalog Number:PN11OTR13 56) KIT, NEURO, Catalog Number:PN11OTR14 57) KIT, NEURO, Catalog Number:PN11OTRM1 58) KIT, NEURO, Catalog Number:PN11OTRM2 59) KIT, NEURO, Catalog Number:PN11OTRM3 60) KIT, NEURO, Catalog Number:PN11OTRM4 61) KIT, NEURO, Catalog Number:PN11OTRM5 62) KIT, NEURO, Cat...
- 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-1134-2025
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) CHIP99NC12, UDI-DI:10195594105471 (each) 50195594105479 (case), Lot Number: J8692J ; 2) CHIP99NC13, UDI-DI:10195594202378 (each) 50195594202376 (case), Lot Number: 5138245 ; 3) CHIP99NC14, UDI-DI:10195594276898 (each) 50195594276896 (case), Lot Number: 5324036 ; 4) CHIP99NC15, UDI-DI:10195594399696 (each) 50195594399694 (case), Lot Number: 5530905 ; 5) CHIP99NC16, UDI-DI:10195594444846 (each) 50195594444844 (case), Lot Number: 5530911 ; 6) CHIP99NC17, UDI-DI:10197106046159 (each) 50197106046157 (case), Lot Number: 6560930 ; 7) CHIP99NC18, UDI-DI:10197106169643 (each) 50197106169641 (case), Lot Number: 6701892 ; 8) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6264447 ; 9) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6986972 ; 10) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 7005424 ; 11) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J4218Z ; 12) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J4678H ; 13) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J4678T ; 14) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J4950P ; 15) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J53W06 ; 16) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: N/A ; 17) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J6049N ; 18) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J6365Y ; 19) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J77Z27 ; 20) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J82M02 ; 21) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: N/A ; 22) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J8393C ; 23) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J84J89 ; 24) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: N/A ; 25) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J6910P ; 26) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: J9602N ; 27) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 5664019 ; 28) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 5664026 ; 29) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 5891284 ; 30) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 5631036 ; 31) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6022056 ; 32) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6264450 ; 33) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6345501 ; 34) CHIP99NC1D, UDI-DI:10888439007954 (each) 50888439007952 (case), Lot Number: 6563903 ; 35) CHIP99NC22, UDI-DI:10195594192273 (each) 50195594192271 (case), Lot Number: 1055391 ; 36) CHIP99NC22, UDI-DI:10195594192273 (each) 50195594192271 (case), Lot Number: 5138240 ; 37) CHIP99NC23, UDI-DI:10195594229412 (each) 50195594229410 (case), Lot Number: 5311235 ; 38) CHIP99NC24, UDI-DI:10195594374297 (each) 50195594374295 (case), Lot Number: 5138222 ; 39) CHIP99NC25, UDI-DI:10195594416966 (each) 50195594416964 (case), Lot Number: 5530901 ; 40) CHIP99NC26, UDI-DI:10195594484736 (each) 50195594484734 (case), Lot Number: 5631034 ; 41) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7332815 ; 42) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7280043 ; 43) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6264447 ; 44) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6905474 ; 45) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7058621 ; 46) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7005446 ; 47) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6701940 ; 48) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7055834 ; 49) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7260062 ; 50) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7260064 ; 51) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7280036 ; 52) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7280061 ; 53) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7160480 ; 54) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7260073 ; 55) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7331292 ; 56) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 7331290 ; 57) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J4678H ; 58) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J4679N ; 59) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J4678W ; 60) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: N/A ; 61) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J5678T ; 62) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J53W12 ; 63) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J6049N ; 64) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J6049Y ; 65) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J77Z26 ; 66) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J7904P ; 67) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J82M03 ; 68) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J8491U ; 69) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J84J86 ; 70) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: N/A ; 71) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J6365Z ; 72) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J96N39 ; 73) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: J6365K ; 74) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 5699520 ; 75) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 5699520 ; 76) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 5891286 ; 77) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6485583 ; 78) CHIP99NC2C, UDI-DI:10888439373141 (each) 50888439373149 (case), Lot Number: 6563907 ; 79) CHIP99SP32, UDI-DI:10195594140274 (each) 50195594140272 (case), Lot Number: 5138228 ; 80) CHIP99SP33, UDI-DI:10195594229733 (each) 50195594229731 (case), Lot Number: 5311233 ; 81) CHIP99SP34, UDI-DI:10195594303280 (each) 50195594303288 (case), Lot Number: 5372220 ; 82) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6022059 ; 83) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6905475 ; 84) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7005449 ; 85) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7055834 ; 86) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7122100 ; 87) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260057 ; 88) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260066 ; 89) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260068 ; 90) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260070 ; 91) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7280037 ; 92) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7260072 ; 93) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7287459 ; 94) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7287469 ; 95) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6485591 ; 96) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7332810 ; 97) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J3986J ; 98) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4678M ; 99) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7332837 ; 100) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4679H ; 101) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4950G ; 102) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 7360138 ; 103) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4950U ; 104) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J4951G ; 105) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: N/A ; 106) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J5678T ; 107) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J8670H ; 108) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J6785Z ; 109) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: J93M83 ; 110) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 5405614 ; 111) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 5631031 ; 112) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 5664020 ; 113) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 5699520 ; 114) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6022054 ; 115) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6345500 ; 116) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6563903 ; 117) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6563910 ; 118) CHIP99SP3D, UDI-DI:10888439373233 (each) 50888439373231 (case), Lot Number: 6701967 ; 119) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J4680A ; 120) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J6049T ; 121) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J6277P ; 122) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J76N01 ; 123) P55VNVP09A, UDI-DI:10888439614749 (each) 50888439614747 (case), Lot Number: J7904R ; 124) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J3986G ; 125) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J4678Z ; 126) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J4679C ; 127) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J4679G ; 128) PGVMACMOQ, UDI-DI:10887488851532 (each) 50887488851530 (case), Lot Number: J4680C ; 129) PN11CNC10, UDI-DI:10195594392536 (each) 50195594392534 (case), Lot Number: 5405610 ; 130) PN11CNC11, UDI-DI:10195594511968 (each) 50195594511966 (case), Lot Number: 5508042 ; 131) PN11CNC12, UDI-DI:10195594565459 (each) 50195594565457 (case), Lot Number: J6049X ; 132) PN11CNC13, UDI-DI:10195594610982 (each) 50195594610980 (case), Lot Number: 5891282 ; 133) PN11CNC14, UDI-DI:10195594774462 (each) 50195594774460 (case), Lot Number: 6022061 ; 134) PN11CNC15, UDI-DI:10195594808952 (each) 50195594808950 (case), Lot Number: 641139... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
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.