Recall archive / FDA device enforcement
Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Cata... — FDA record Z-1135-2025
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 SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:PN29LMFGA 10) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM4 11) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM5 12) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM6 13) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM7 14) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM8 15) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM9 16) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMA 17) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMB 18) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMC 19) KIT, BACK, Catalog Number:PN33BPC10 20) KIT, BACK, Catalog Number:PN33BPC11 21) KIT, BACK, Catalog Number:PN33BPCR1 22) KIT, BACK, Catalog Number:PN33BPCR2 23) KIT, BACK, Catalog Number:PN33BPCR3 24) KIT, BACK, Catalog Number:PN33BPCR4 25) KIT, BACK, Catalog Number:PN33BPCR5 26) KIT, BACK, Catalog Number:PN33BPCR6 27) KIT, BACK, Catalog Number:PN33BPCR7 28) KIT, BACK, Catalog Number:PN33BPCR8 29) KIT, BACK, Catalog Number:PN33BPCR9 30) KIT, BACK, Catalog Number:PN33BPCRA 31) KIT, BACK, Catalog Number:PN33BPCRB 32) KIT, BACK, Catalog Number:PN33BPCRC 33) KIT, MAJOR SPINE, Catalog Number:PN33MSOCG 34) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU1 35) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU2 36) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUA 37) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUB 38) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUC 39) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUD 40) KIT, LAMINECTOMY, Catalog Number:PN41LMMYA 41) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA1 42) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA2 43) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA3 44) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA4 45) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU2 46) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU3 47) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU4 48) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU5 49) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU6 50) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU7 51) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAUJ 52) KIT, SPINE, Catalog Number:PNCGKSPI1 53) KIT, ACDF, Catalog Number:PNMVASNL1 54) KIT, ACDF, Catalog Number:PNMVASNL2 55) KIT, ACDF, Catalog Number:PNMVASNLA 56) KIT, ACDF, Catalog Number:PNMVASNLB 57) KIT, ACDF, Catalog Number:PNMVASNLC 58) KIT, LAMINECTOMY, Catalog Number:PNMVLMNL2 59) KIT, LAMINECTOMY, Catalog Number:...
- 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
- 793,785 total units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1135-2025
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) CHIP99SP11, UDI-DI:10195594137595 (each) 50195594137593 (case), Lot Number: 5138229 ; 2) CHIP99SP12, UDI-DI:10195594268466 (each) 50195594268464 (case), Lot Number: 5324036 ; 3) CHIP99SP13, UDI-DI:10197106271377 (each) 50197106271375 (case), Lot Number: 6907769 ; 4) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7045815 ; 5) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7280043 ; 6) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701891 ; 7) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701938 ; 8) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6986974 ; 9) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7005449 ; 10) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7055825 ; 11) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7160425 ; 12) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7260062 ; 13) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7280062 ; 14) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7287465 ; 15) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6485588 ; 16) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7331290 ; 17) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4218Z ; 18) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4678H ; 19) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4678J ; 20) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7332809 ; 21) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4678P ; 22) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7332837 ; 23) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7332837 ; 24) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4680D ; 25) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J53W07 ; 26) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J53W10 ; 27) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6049N ; 28) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6277R ; 29) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: N/A ; 30) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6277W ; 31) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6365T ; 32) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J72P49 ; 33) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J72P49 ; 34) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J82K97 ; 35) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: N/A ; 36) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J8123N ; 37) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J8393C ; 38) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J93M83 ; 39) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5372220 ; 40) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5530888 ; 41) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5530904 ; 42) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5631043 ; 43) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5664019 ; 44) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6049X ; 45) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5699520 ; 46) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5775787 ; 47) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5775788 ; 48) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6025763 ; 49) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6022051 ; 50) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6264448 ; 51) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6183268 ; 52) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6411401 ; 53) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6485582 ; 54) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6560931 ; 55) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701948 ; 56) CHIP99SP22, UDI-DI:10195594006723 (each) 50195594006721 (case), Lot Number: J96N37 ; 57) CHIP99SP23, UDI-DI:10195594158040 (each) 50195594158048 (case), Lot Number: 5138235 ; 58) CHIP99SP24, UDI-DI:10195594307745 (each) 50195594307743 (case), Lot Number: 5508040 ; 59) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7280043 ; 60) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6264449 ; 61) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6905474 ; 62) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7005424 ; 63) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7121998 ; 64) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6701940 ; 65) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7055833 ; 66) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7122072 ; 67) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7122098 ; 68) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7160425 ; 69) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7286183 ; 70) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7280044 ; 71) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7260072 ; 72) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7287471 ; 73) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7348991 ; 74) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4218Z ; 75) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7332810 ; 76) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4678X ; 77) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4679T ; 78) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4950P ; 79) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4950W ; 80) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J53W19 ; 81) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: N/A ; 82) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J6049M ; 83) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J6277P ; 84) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J68T51 ; 85) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J7412G ; 86) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J72P49 ; 87) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: PO962497 ; 88) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5530888 ; 89) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5530911 ; 90) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5631040 ; 91) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J6049Z ; 92) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J53W15 ; 93) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5775787 ; 94) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5664021 ; 95) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6022055 ; 96) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6345502 ; 97) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5530909 ; 98) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6563906 ; 99) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6563795 ; 100) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6687065 ; 101) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7280076 ; 102) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7287537 ; 103) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7287473 ; 104) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7331317 ; 105) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7287463 ; 106) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7287534 ; 107) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7332810 ; 108) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7332870 ; 109) PN29PSLM4, UDI-DI:10195594301002 (each) 50195594301000 (case), Lot Number: 5324048 ; 110) PN29PSLM5, UDI-DI:10195594592653 (each) 50195594592651 (case), Lot Number: 5664025 ; 111) PN29PSLM6, UDI-DI:10195594632403 (each) 50195594632401 (case), Lot Number: 5775787 ; 112) PN29PSLM7, UDI-DI:10195594728694 (each) 50195594728692 (case), Lot Number: 6025764 ; 113) PN29PSLM8, UDI-DI:10197106531891 (each) 50197106531899 (case), Lot Number: 7160479 ; 114) PN29PSLM9, UDI-DI:10197106567555 (each) 50197106567553 (case), Lot Number: 7280061 ; 115) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: J7267D ; 116) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: 5405610 ; 117) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: 5530908 ; 118) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: 5631042 ; 119) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: J6365M ; 120) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: 5891291 ; 121) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6701938 ; 122) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6986974 ; 123) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 7005426 ; 124) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6264449 ; 125) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6485573 ; 126) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6563906 ; 127) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6568661 ; 128) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6568661 ; 129) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7122097 ; 130) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7284052 ; 131) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7160478 ; 132) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7287472 ; 133) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7287463 ; 134) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: ... |
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.