Recall Z-2949-2026 ยท OJK Eye Tray
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B
| Date | Aug 13, 2026 (initiated Jul 14, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 616 kits |
| Distribution | US Nationwide. Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.