The Recall Desk
HighFDA (Devices)·Z-1133-2025·Announced 2025-02-19

Cardinal Health Robotic Hysterectomy Kits Recalled for Endotoxin Contamination

Cardinal Health is recalling Presource Robotic Hysterectomy Kits due to potential endotoxin contamination in surgical strips and patties. Endotoxins are bacterial contaminants that could cause complications during surgical procedures.

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 FDA Class II recall involves surgical equipment with potential endotoxin contamination, a serious biological hazard in sterile surgical fields. No illnesses or injuries have been reported, making this a risk-of-harm product with a theoretical hazard consistent with High severity.

Plain-English summary

Cardinal Health 200, LLC is recalling Presource Robotic Hysterectomy Kits due to potential endotoxin contamination in the non-sterile surgical strips and patties included in the kits. Three catalog numbers are affected (PB4FRHWFA, PB4FRHWFB, and PB4FRHWFC) and have been distributed nationwide in the US, Canada, and Saudi Arabia, totaling approximately 973,785 units.

Endotoxins are bacterial contaminants that could cause complications if present during surgical procedures. The recall was issued to prevent these materials from being used in robotic hysterectomy procedures.

Healthcare facilities that have received these kits should inspect their inventory against the affected lot numbers identified in this recall. Affected lot numbers include 6701856, 7331357, 7266123, 7333452, 7333453, 7160530, and 7350003. Facilities should contact Cardinal Health or the FDA for guidance on management of affected kits.

The recalled product

Product
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Kit
Hazard
Affected units
973,785

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 (19)

  • 1) PB4FRHWFA
  • UDI-DI:10197106527009 (each) 50197106527007 (case)
  • Lot Number: 6701856
  • 2) PB4FRHWFA
  • Lot Number: 7331357
  • 3) PB4FRHWFB
  • UDI-DI:10197106628096 (each) 50197106628094 (case)
  • Lot Number: 7266123
  • 4) PB4FRHWFB
  • 5) PB4FRHWFB
  • Lot Number: 7333452
  • 6) PB4FRHWFB
  • Lot Number: 7333453
  • 7) PB4FRHWFB
  • Lot Number: 7160530
  • 8) PB4FRHWFB
  • 9) PB4FRHWFC
  • UDI-DI:10197106732311 (each) 50197106732319 (case)
  • Lot Number: 7350003

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Related recalls

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · endotoxin contamination

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