The Recall Desk
HighFDA (Devices)·Z-0915-2025·Announced 2025-01-22

Cardinal Health surgical kits recalled for potential endotoxin contamination

Cardinal Health Presource surgical kits are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units were distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving potential endotoxin contamination in surgical kits used in procedures where infection poses significant risk. No illnesses or injuries are reported in the source material, and the hazard is theoretical rather than confirmed. Per the severity rubric, this qualifies as 'High' for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Cardinal Health is recalling multiple Presource surgical kit models containing non-sterile surgical strips and patties used in neurosurgery and spine surgical procedures. Approximately 512,786 units have been distributed.

The kits are being recalled due to potential endotoxin contamination in the non-sterile surgical strips and patties. Endotoxins are bacterial contaminants that can pose a risk of infection during surgical use.

The affected kits were distributed worldwide, including to hospitals and surgical centers in the United States, Canada, and Saudi Arabia.

Healthcare providers and facilities that have received affected kits should immediately discontinue use and contact Cardinal Health for replacement or return instructions. For additional information, refer to FDA recall number Z-0915-2025.

The recalled product

Product
Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5) CHI STD NEURO CR
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Kits
Hazard
  • endotoxin
  • bacterial-contamination
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Catalog Number 2NE69CNK12
  • UDI/DI 10195594412845 (EA)50195594412843 (CS)
  • Lot Number 5631070
  • Lot Number 5530905
  • Lot Number 5138271
  • Lot Number 5533340
  • Catalog Number CHIP99NC42
  • UDI/DI 10195594124007 (EA)50195594124005 (CS)
  • Lot Number 5136018
  • Lot Number 5136034
  • Lot Number 5136012
  • Lot Number 5136019
  • Catalog Number CHIP99NC43
  • UDI/DI 10195594247867 (EA)50195594247865 (CS)
  • Lot Number 5140342
  • Lot Number 5324034
  • Lot Number 5138327
  • Lot Number 5140378
  • Catalog Number CHIP99NC44
  • UDI/DI 10195594272777 (EA)50195594272775 (CS)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category