Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Endotoxins could pose a risk if contaminated components are used in sterile surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves potential endotoxin contamination in surgical supply kits—a high-risk bacterial hazard in a surgical context. Although no illnesses or injuries have been reported, endotoxins pose a significant risk of harm if contaminated supplies are used in sterile surgical procedures.
Plain-English summary
Cardinal Health 200, LLC is recalling multiple lots of Presource surgical kits containing non-sterile surgical strips and patties due to potential endotoxin contamination. The affected products are used in head and neck procedures, ear/nose/throat procedures, and plastic eye procedures across multiple surgical specialties.
Endotoxins are bacterial byproducts that can trigger inflammatory reactions or infection if they contaminate sterile surgical fields. The contamination could compromise the sterility of surgical procedures if contaminated kit components come into contact with sterile areas during use.
The recall affects 512,786 units distributed worldwide, including to healthcare facilities in the United States, Canada, and Saudi Arabia. Healthcare facilities should discontinue use of the affected lots immediately and contact Cardinal Health for return and replacement instructions.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH3; 5) KIT,H N FREE FLAP , Catalog…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Supply
- Hazard
- Affected units
- 512,786
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 PEHFHNAMHJ
- UDI/DI 10888439038620 (EA)50888439038628 (CS)
- Lot Number J43U76
- Lot Number J43U77
- Catalog Number PWHFHNAMH1
- UDI/DI 10888439744729 (EA)50888439744727 (CS)
- Lot Number J34J42
- Catalog Number PWHFHNAMH2
- UDI/DI 10195594014018 (EA)50195594014016 (CS)
- Lot Number J8124C
- Catalog Number PWHFHNAMH3
- UDI/DI 10195594343477 (EA)50195594343475 (CS)
- Lot Number 5478802
- Catalog Number PWHFHNAMH4
- UDI/DI 10197106340523 (EA)50197106340521 (CS)
- Lot Number 6702010
- Catalog Number PWHFHNAMH5
- UDI/DI 10197106497425 (EA)50197106497423 (CS)
- Lot Number 6928766
- Catalog Number PWHFHNAMH6
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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 10 products in this recall →Related recalls
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