Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
Cardinal Health 200, LLC is recalling 52,699 Presource surgical kits because they contain MEDICOM Ritmed Neurological 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 medical device with a known defect (endotoxin variability) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling 52,699 Presource surgical kits distributed in the United States and Canada. The recall affects various catalog numbers, including PN33NBMYD, PN36NBCH4, PN36NBCH5, PN41ACLA9, and others, across multiple lot numbers.
The reason for the recall is that these procedure kits contain MEDICOM Ritmed Neurological Sponges that were previously recalled due to unexpected variability in endotoxin levels. Endotoxins are substances that can cause adverse reactions in patients when introduced into the body during surgery.
Healthcare facilities and distributors should stop using these specific kits and check their inventory against the provided catalog numbers and lot numbers. Affected units should be returned to Cardinal Health 200, LLC or the original supplier for credit or replacement, in accordance with the company's recall instructions.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 52,699
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) PN33NBMYD
- UDI-DI: 10198956187474(each)
- 50198956187472(case)
- Lot Number: 15463-6
- 2) PN33NBMYD
- 3) PN33NBMYD
- Lot Number: 14039
- 4) PN33NBMYD
- 5) PN33NBMYD
- Lot Number: 14813
- 6) PN33NBMYD
- Lot Number: 15192
- 7) PN33NBMYD
- 8) PN33NBMYD
- 9) PN36NBCH4
- UDI-DI: 10198956129863(each)
- 50198956129861(case)
- 10) PN36NBCH5
- UDI-DI: 10198956131538(each)
- 50198956131536(case)
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Cardinal Health 200, LLC
See all →- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
- ModerateProcedure kits with MEDICOM Ritmed Neurological Sponges are recalled due to endotoxin variability.
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
Same hazard · endotoxin variability
See all →- HighMedicom Recalls Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-08-26
- HighMedicom Recalls Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-08-26
- HighCardinal Health Recalls Neurological Procedure Kits Due to Endotoxin Variability
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-08-19