PlainRecalls
ModerateClass IIOngoing

FDA Devices recall · Reported February 19, 2025

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:P

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Recall #
Z-1135-2025
Affected scope
793,785 total units
Initiated
November 8, 2024
Compiled from official public sources by the publisher.
Verify with FDA Devices →
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Cardinal Health 200, LLC recalled Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) … - a moderate-severity action.

Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) … was recalled by Cardinal Health 200, LLC in February 19, 2025. Reason: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.. Check the official notice for the remedy. Verify recall #Z-1135-2025 with the FDA Devices before acting.

The recall

Cardinal Health 200, LLC issued this moderate-severity FDA Devices recall-Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits..

Moderate
severity level
Class II
classification
February 19, 2025
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1135-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices and 2 from Cardinal Health 200, LLC - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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:PNMVLMNL3 60) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLA 61) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLB 62) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLC 63) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLD 64) KIT, SPINE FUSION, Catalog Number:PNMVSF454 65) KIT, SPINE FUSION, Catalog Number:PNMVSF45A 66) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA1 67) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA2 68) KIT,CRANIOTOMY, Catalog Number:PNOCCRZAA 69) KIT,LAMINECTOMY, Catalog Number:PNOCLAZA1 70) KIT,LAMINECTOMY, Catalog Number:PNOCLAZAA 71) KIT, LAMINECTOMY, Catalog Number:PNOCLAZAB 72) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH11 73) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH12 74) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH13 75) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH14 76) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH15 77) SPINE, HUNTINGTON, Catalog Number:PNOCSPHTU 78) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTV 79) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTW 80) KIT, ORTHO C

Reason for recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number Z-1135-2025
Date reported February 19, 2025
Date initiated November 8, 2024
Recalling firm Cardinal Health 200, LLC
Firm location Waukegan, IL
Affected scope 793,785 total units
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1135-2025) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
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:PNMVLMNL3 60) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLA 61) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLB 62) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLC 63) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLD 64) KIT, SPINE FUSION, Catalog Number:PNMVSF454 65) KIT, SPINE FUSION, Catalog Number:PNMVSF45A 66) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA1 67) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA2 68) KIT,CRANIOTOMY, Catalog Number:PNOCCRZAA 69) KIT,LAMINECTOMY, Catalog Number:PNOCLAZA1 70) KIT,LAMINECTOMY, Catalog Number:PNOCLAZAA 71) KIT, LAMINECTOMY, Catalog Number:PNOCLAZAB 72) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH11 73) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH12 74) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH13 75) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH14 76) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH15 77) SPINE, HUNTINGTON, Catalog Number:PNOCSPHTU 78) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTV 79) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTW 80) KIT, ORTHO C. Recalled by Cardinal Health 200, LLC. Units affected: 793,785 total units.
Why was this product recalled? ▼
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2025. Severity: Moderate. Recall number: Z-1135-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia..
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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