Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
Cardinal Health is recalling 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, a risk-of-harm condition where no injuries have been reported, fitting the 'High' severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling specific Presource Kits, including ENT, Sinus, Nasal Septoplasty, Head and Neck, and EENT kits. The recall is due to the inclusion of MEDICOM Ritmed Neurological Sponges that exhibit unexpected variability in endotoxin levels.
The affected products were distributed nationwide in the United States and in Canada. The source text does not specify the exact number of units affected or report any illnesses or injuries associated with the use of these kits.
Healthcare facilities and consumers should stop using the affected kits and contact Cardinal Health for further instructions or a replacement.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 87,182
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) 24-0726A
- UDI-DI: 10195594855130(each)
- 50195594855138(case)
- Lot Number: 4730
- 2) 24-0726A
- 3) 24-0726A
- 4) 24-0726A
- Lot Number: 3747
- 5) PE13SPAJA
- UDI-DI: 10195594732189(each)
- 50195594732187(case)
- Lot Number: 4366
- 6) PE13SPAJA
- Lot Number: 2390
- 7) PE13SPAJA
- Lot Number: 265098
- 8) PE13SPAJB
- UDI-DI: 10197106290910(each)
- 50197106290918(case)
- Lot Number: 7390
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Cardinal Health 200, LLC
See all →- SevereCardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
Same hazard · endotoxin variability
See all →- HighAVID Medical Recalls Halyard Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-09-09
- HighAVID Medical Recalls Halyard Kits Due to Endotoxin Variability
FDA (Devices) · 2026-09-09
- HighAVID Medical Recalls Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-09-09
- 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
Similar recalls
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
- 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
- ModerateProcedure kits with MEDICOM Ritmed Neurological Sponges are recalled due to endotoxin variability.
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2025-02-19
- HighCardinal Health Presource Kits recalled for endotoxin contamination risk
FDA (Devices) · 2025-02-19