The Recall Desk
HighFDA (Devices)·Z-0914-2025·Announced 2025-01-22

Cardinal Health Fetal Surgery Kits Recalled for Endotoxin Contamination Risk

Cardinal Health is recalling Presource fetal surgery kits due to potential endotoxin contamination in non-sterile surgical strips and patties, which could pose infection risk.

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: FDA Class II without reported illnesses or injuries. The hazard is potential rather than confirmed, so severity is capped at High per the rubric.

Plain-English summary

Cardinal Health 200, LLC is recalling multiple Presource surgical kit models used for fetal surgery procedures. Approximately 512,786 units have been distributed worldwide, including the United States, Canada, and Saudi Arabia. The recalled kits are identified by catalog numbers PB11FSC10, PB11FSCH5, PB11FSCH6, PB11FSCH7, PB11FSCH8, PB11FSCH9, and PB11FSCHR.

The kits are being recalled due to potential endotoxin contamination in the non-sterile surgical strips and patties included in the kits. Endotoxin exposure in surgical settings can increase the risk of infection.

Healthcare facilities that have received these kits should discontinue use and contact Cardinal Health for information on replacement products. Patients who have had surgery using these kits should contact their healthcare provider if they experience signs of infection.

The recalled product

Product
Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7 5 ) KIT, FETAL SURGERY , Catalog Number PB11
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Supplies
Hazard
  • endotoxin-contamination
  • sterility-failure
  • 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 PB11FSC10
  • UDI/DI 10197106452042 (EA)50197106452040 (CS)
  • Lot Number 6928760
  • Catalog Number PB11FSCH5
  • UDI/DI 10195594665951 (EA)50195594665959 (CS)
  • Lot Number 5891312
  • Catalog Number PB11FSCH6
  • UDI/DI 10195594760984 (EA)50195594760982 (CS)
  • Lot Number 6022131
  • Catalog Number PB11FSCH7
  • UDI/DI 10195594788704 (EA)50195594788702 (CS)
  • Lot Number 6025788
  • Catalog Number PB11FSCH8
  • UDI/DI 10197106000229 (EA)50197106000227 (CS)
  • Lot Number J6278R
  • Catalog Number PB11FSCH9
  • UDI/DI 10197106404751 (EA)50197106404759 (CS)
  • Lot Number 6788562
  • Catalog Number PB11FSCHR
  • UDI/DI 10195594890407 (EA)50195594890405 (CS)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category