# FDA recall Z-1135-2025 > **Cardinal Health 200, LLC** · Class II · device recall initiated 2024-11-08. ## 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, Cat ## Reason for recall Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. ## Distribution Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia. ## Key facts - **Recall number:** Z-1135-2025 - **Recalling firm:** Cardinal Health 200, LLC - **Classification:** Class II - **Product type:** device - **Status:** Ongoing - **Initiation date:** 2024-11-08 - **Report date:** 2025-02-19 - **Voluntary/Mandated:** Voluntary: Firm initiated - **Location:** Waukegan, IL, United States ## Primary source FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1135-2025 ## Citation > AI Analytics. FDA recall Z-1135-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1135-2025. Source: US FDA. Licensed CC0. --- *[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*