Recall Z-2944-2026
Cardinal Health 200, LLC · initiated July 14, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
Codes / lots: 1) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15192 ; 2) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15463-1
Reason for recall
Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.
FDA-determined cause: Nonconforming Material/Component
Action taken
Cardinal Health issued an URGENT: PRODUCT CORRECTION notice to its consignees on 7/14/2026 via FedEx. The notice explained the issue and enclosed a copy of the recall notice issued by the supplier of the affected component which explained the risk and provided details on the affected component. The notice issued by Cardinal Health requested that consignee notify its clinicians, affix a warning label to the affected kits in their inventory, and respond using the acknowledgement form via fax to 614.652.9648. Additional labels will be sent to your facility upon request. Please send an email to: gmb-FieldCorrectiveAction@cardinalhealth.com. The warning label requests that the affected component be removed and discarded. For component credit or replacement, please contact the following: " Hospitals Cardinal Customer Service at 866.551.0533 " Distributors Distributor Management at 800.635.6021 " Federal Government facilities Government Customer Service at 800.444.1166. Distributors were direct to notify their customers. For questions, additional labels, or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.
Details
- Recall number
- Z-2944-2026
- Initiated
- July 14, 2026
- Posted by FDA
- August 13, 2026
- Product code
- OEZ – Cardiovascular Procedure Kit
- Quantity
- 80 kits
- Distribution
- US Nationwide. Canada.
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2942-2026 Class II | Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | 07/14/2026Open, Classified |
| Z-2943-2026 Class II | Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number:…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | 07/14/2026Open, Classified |
| Z-2945-2026 Class II | Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | 07/14/2026Open, Classified |
| Z-2946-2026 Class II | Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2)…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | 07/14/2026Open, Classified |
| Z-2947-2026 Class II | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number:…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | 07/14/2026Open, Classified |
| Z-2948-2026 Class II | Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2)…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | 07/14/2026Open, Classified |
| Z-2949-2026 Class II | Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | 07/14/2026Open, Classified |