Cardinal Health Urology Robotic Packs recalled for potential endotoxin contamination
Cardinal Health Presource Kits for robotic urology surgery are being recalled due to potential endotoxin contamination in surgical strips and patties. No adverse events have been reported.
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 recall of medical devices with potential endotoxin contamination in sterile surgical supplies. While no illnesses have been reported, endotoxin contamination poses a risk in surgical applications.
Plain-English summary
Cardinal Health Presource Kits for robotic urology procedures are being recalled due to potential endotoxin contamination in the surgical strips and patties included in these kits. Approximately 973,785 units are affected, distributed in the United States and internationally to Canada and Saudi Arabia.
The recall was classified as FDA Class II. Three catalog numbers are involved in this action: SOT4FRUWFA, SOT4FRUWFB, and SOT4FRUWFC.
Healthcare facilities that have received these kits should check their inventory against the recalled lot numbers and catalog numbers. Healthcare providers should discontinue use of affected supplies immediately.
Affected parties should contact Cardinal Health for instructions on returning recalled kits and obtaining replacements. Any adverse events or health concerns related to use of these kits should be reported to the FDA.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- endotoxin
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 (14)
- 1) SOT4FRUWFA
- UDI-DI:10197106526187 (each) 50197106526185 (case)
- Lot Number: 7266123
- 2) SOT4FRUWFA
- Lot Number: 7331357
- 3) SOT4FRUWFB
- UDI-DI:10197106627891 (each) 50197106627899 (case)
- 4) SOT4FRUWFB
- Lot Number: 7333452
- 5) SOT4FRUWFB
- Lot Number: 7333453
- 6) SOT4FRUWFC
- UDI-DI:10197106732304 (each) 50197106732302 (case)
- Lot Number: 7350031
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03