Procedure kits with MEDICOM Ritmed Neurological Sponges are recalled due to endotoxin variability.
The FDA is recalling procedure kits containing MEDICOM Ritmed Neurological Sponges because of unexpected variability in endotoxin levels. This affects consumers who have received or plan to receive these kits.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves a Class II medical device with potential infection risk from endotoxin variability, but no reported illnesses or injuries. Per the rubric, this qualifies as a moderate risk where injury has not yet been reported.
Plain-English summary
The FDA is recalling procedure kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels. This safety issue was identified during testing and requires removal from circulation to prevent potential health risks associated with inconsistent microbial contamination.
These kits are used by healthcare professionals in neurological procedures. Any patients or providers who have received or intend to use these specific procedure kits should discontinue use immediately and contact their healthcare facility for guidance.
Consumers are advised to check with their physician or local health authority for specific instructions regarding disposal or return of recalled items. The recall covers all lots distributed nationwide and internationally through Canada.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Procedure Kits
- Hazard
- Affected units
- 36,862
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) 21-4720B
- UDI-DI: 10888439934663(each)
- 50888439934661(case)
- Lot Number: 94970
- 2) 21-4720C
- UDI-DI: 10197106675793(each)
- 50197106675791(case)
- Lot Number: 10339
- 3) 21-4720C
- Lot Number: 10586
- 4) PECGMLBOB
- UDI-DI: 10197106067406(each)
- 50197106067404(case)
- Lot Number: 4366
- 5) PECGNAAU8
- UDI-DI: 10197106967706(each)
- 50197106967704(case)
- Lot Number: 12206
- 6) PECGNAAUJ
- UDI-DI: 10197106894514(each)
Distribution
Distributed nationwide across the United States.
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