# FDA recall Z-0916-2025

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2024-11-08.

## Product

Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON    , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE    , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE    , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY8; 10) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYD; 11) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYE; 12) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYF; 13) KIT, SPINE   , Catalog Number: PN40SPMMA; 14) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY1; 15) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY2; 16) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY3; 17) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY4; 18) KIT, ORTHO LAMINECTOMY , Cat

## Reason for recall

Potential 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-0916-2025
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-08
- **Report date:** 2025-01-22

- **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-0916-2025

## Citation

> AI Analytics. FDA recall Z-0916-2025. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-0916-2025. Source: US FDA. Licensed CC0.

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