Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2

FDA device recall Z-2947-2026 · posted 2026-08-13 · Open, Classified

Recall details

Recalling firm

Cardinal Health 200, LLC

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.

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

OJG

Quantity affected

401311 kits

Distribution

US Nationwide. Canada.

Date initiated

2026-07-14

Date posted

2026-08-13

Location

Waukegan, IL