# FDA recall Z-1126-2025

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

## Product

Cardinal Health Presource Kits:  1) KIT,DIEP FLAP                 , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP                 , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP                 , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP                 , Catalog Number:PB23DFCM6; 5) KIT,DIEP FLAP                 , Catalog Number:PB23DFCM7; 6) KIT,DIEP FLAP                 , Catalog Number:PB23DFCMA; 7) KIT, HEAD AND NECK            , Catalog Number:PE40HNAJ10; 8) KIT, HEAD AND NECK            , Catalog Number:PE40HNAJ11; 9) KIT, HEAD AND NECK            , Catalog Number:PE40HNAJ12; 10) KIT, HEAD AND NECK            , Catalog Number:PE40HNAJ13; 11) KIT, HEAD AND NECK            , Catalog Number:PE40HNAJ14; 12) KIT, HEAD AND NECK            , Catalog Number:PE40HNAJ15; 13) KIT, HEAD AND NECK            , Catalog Number:PE40HNAJ16; 14) KIT, HEAD AND NECK            , Catalog Number:PE40HNAJ17; 15) KIT, HEAD AND NECK            , Catalog Number:PE40HNAJ18; 16) KIT, HEAD AND NECK            , C

## 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-1126-2025
- **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-1126-2025

## Citation

> AI Analytics. FDA recall Z-1126-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1126-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*