FDAFDA recall Z-2944-2026 · Aug 19, 2026
Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) NEWNAN SMR PACK recall
Recall found
Product
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
Reason for recall
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 1) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15192 ; 2) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15463-1
- Quantity
- 80 kits
- Distribution
- US Nationwide. Canada.
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-14
Source: openFDA enforcement record Z-2944-2026 · search recall number Z-2944-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.