Surgical Kit Recall: Potential Endotoxin Contamination in Cardinal Health Presource Kits
Cardinal Health recalls Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Affected units were distributed in the US, Canada, and Saudi Arabia.
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 for potential endotoxin contamination in surgical materials used in clinical procedures. No reported illnesses or injuries documented in the source. Per FDA severity rubric, theoretical hazards in risk-of-harm medical devices score at most 3 (High).
Plain-English summary
Cardinal Health 200, LLC is recalling multiple Presource kit models, including Triple Endo Packs and Riverside Sinus Endoscopy Packs, totaling 512,786 units.
The kits contain non-sterile surgical strips and patties that may have potential endotoxin contamination. Endotoxins are bacterial toxins that can trigger inflammatory responses and pose an infection risk in surgical procedures.
The affected kits were distributed worldwide, including to healthcare facilities in the United States, Canada, and Saudi Arabia. Specific lot numbers and catalog numbers are identified in the official recall notice.
Healthcare facilities should discontinue use of affected units immediately and contact Cardinal Health for replacements. Patients who underwent surgical procedures using potentially affected kits should consult their healthcare provider if they develop signs of infection.
The recalled product
- Product
- Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE S
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- endotoxin-contamination
- sterility-defect
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 SBAOCTEHH1
- UDI/DI 10195594722685 (EA)50195594722683 (CS)
- Lot Number 21J2883
- Catalog Number SBAOCTEHHA
- UDI/DI 10888439551662 (EA)50888439551660 (CS)
- Lot Number 22D1028
- Lot Number 24C0535
- Lot Number 22D1029
- Lot Number 23F1437
- Lot Number 18E1332
- Lot Number 18H2278
- Lot Number 18J2582
- Lot Number 18M3535
- Lot Number 19A0124
- Lot Number 19E1525
- Lot Number 19K3308
- Lot Number N/A
- Lot Number 19C0888
- Lot Number 19B0560
- Catalog Number SEN15SERM5
Distribution
Distributed nationwide across the United States.
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