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
- endotoxin-contamination
- sterility-failure
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.
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