Agency classClass IIOur severity:High FDA (Devices)·Z-2947-2026·Announced 2026-08-19

Cardinal Health Recalls Neurological Procedure Kits Due to Endotoxin Variability

Cardinal Health is recalling specific Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.

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 is classified as FDA Class II, and the hazard involves endotoxin variability in a medical device used in neurological procedures, which poses a risk of harm even without reported illnesses.

Plain-English summary

Cardinal Health 200, LLC is recalling specific Presource Kits, including various Neuro Crani Opt and ENT kits, because they contain MEDICOM Ritmed Neurological Sponges. The recall was initiated due to unexpected variability in endotoxin levels within these sponges.

The affected products were distributed nationwide in the United States and in Canada. The recall covers 401,311 kits across multiple catalog numbers and lot numbers.

Healthcare facilities and consumers should check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to the instructions provided by Cardinal Health.

The recalled product

Product: Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number…
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Kits
Hazard: endotoxin-variability
Affected units: 401,311

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)

3790) SNE30CNRCD
UDI-DI: 10195594687052(each)
50195594687050(case)
Lot Number: 4730
3791) SNE30CNRCD
Lot Number: 2221315564
3792) SNE30CNRCD
Lot Number: 338058
3793) SNE30CNRCD
Lot Number: 4869
3794) SNE30CNRCD
Lot Number: 7784
3795) SNE30CNRCD
3796) SNE30CNRCD
3797) SNE30CNRCD
3798) SNE30CNRCD
3799) SNE30CNRCD
Lot Number: 9243-1
3800) SNE30CNRCD
Lot Number: 3024-2

Distribution

Distributed nationwide across the United States.

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · endotoxin variability