Cardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. No illnesses have been reported.
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: FDA Class II recall for endotoxin contamination in surgical kits, representing a serious potential hazard in medical contexts. No illnesses or injuries have been reported to date; the contamination is potential rather than confirmed in use.
Plain-English summary
Cardinal Health is recalling multiple Presource surgical kit models (512,786 total units) distributed worldwide including the United States, Canada, and Saudi Arabia. The affected kits contain non-sterile surgical strips and patties that may be contaminated with endotoxins.
Endotoxins are bacterial contaminants that can pose serious risks in medical applications. The recall encompasses kits with numerous catalog numbers across different surgical specialties, including rhinoplasty, reconstruction, and maxillofacial procedures.
The FDA classified this as a Class II recall. Affected products can be identified by their catalog numbers and lot numbers, which are listed in the manufacturer's detailed recall information.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- 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 PGHDOT951
- UDI/DI 10888439692228 (EA)50888439692226 (CS)
- Lot Number J4952D
- Catalog Number PGHDOT952
- UDI/DI 10888439821260 (EA)50888439821268 (CS)
- Lot Number J6050F
- Catalog Number PWHDOT910
- UDI/DI 10197106435052 (EA)50197106435050 (CS)
- Lot Number 6788561
- Catalog Number PWHDOT911
- UDI/DI 10197106646724 (EA)50197106646722 (CS)
- Lot Number 7332903
- Catalog Number PWHDOT912
- UDI/DI 10197106673195 (EA)50197106673193 (CS)
- Lot Number 7163082
- Catalog Number PWHDOT913
- UDI/DI 10197106713365 (EA)50197106713363 (CS)
- Lot Number 7332912
- Catalog Number PWHDOT914
- UDI/DI 10197106718834 (EA)50197106718832 (CS)
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.
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