Cardinal Health Presource Kits Recalled for Endotoxin Variability
Cardinal Health is recalling 616 Presource Kits because they contain sponges with unexpected endotoxin variability.
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: The recall involves a Class II medical device with a risk of harm (endotoxin variability) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cardinal Health 200, LLC is recalling 616 units of Presource Kits, including Basic, Spine, and Craniotomy packs. The recall is due to the inclusion of MEDICOM Ritmed Neurological Sponges that were previously recalled for unexpected variability in endotoxin levels.
The affected kits were distributed nationwide in the United States and in Canada. The source text does not specify the exact dates of distribution or the specific medical facilities where the kits were used.
Healthcare providers and consumers should check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice. If the affected products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: S
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 616
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)
- 1) SBA73BPGCA
- UDI-DI: 10888439874891(each)
- 50888439874899(case)
- Lot Number: 14039
- 2) SNE11SPHKC
- UDI-DI: 10197106817186(each)
- 50197106817184(case)
- Lot Number: 12206
- 3) SNE11SPHKC
- 4) SNE11SPHKC
- 5) SNE11SPHKC
- Lot Number: 15192-1
- 6) SNE11SPHKC
- Lot Number: 15463-5
- 7) SNE11SPHKC
- Lot Number: 11020-1
- 8) SNE11SPHKC
- 9) SNE11SPHKC
- Lot Number: 14813
- 10) SNE11SPHKC
Distribution
Distributed nationwide across the United States.
Related recalls
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Same hazard · endotoxin variability
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FDA (Devices) · 2026-08-19